In-house & bespoke training:
Medical Devices
With our extensive faculty of expert speakers with experience in the field of medical devices, we deliver a variety of medical device training courses that are relevant, will keep you abreast of regulatory changes, are highly interactive and offer a great opportunity for you to network with others working in the medical device industry.
The constant development of new medical devices, alongside changes and updates to regulations, create an ever-changing landscape in the medical device field Whether you are looking to develop your understanding of drug/delivery combination products, keep up-to-date with the latest EU and FDA regulatory requirements, learn about clinical studies, or hear the latest on the use of medical device software and emerging technologies. Management Forum offers a wide selection of medical device training courses for you to extend your knowledge, hear the latest regulatory updates and focus on particular areas of Medical Devices.
Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book
A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK
In-house & bespoke training
This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.
Rated by attendees to the public programme
Typically presented by
Theresa Jeary (bio)
and 3 more leading experts
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Advanced Regulatory Affairs for Medical Devices
In-house & bespoke training
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Rated by attendees to the public programme
Typically presented by Theresa Jeary (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
AI & ML in Clinical Trials: Fundamentals, Applications, and Regulatory Aspects
In-house & bespoke training
AI and Machine Learning are revolutionising clinical trial data management by enhancing efficiency, streamlining processes, and minimising human error. This course will be of use in both the pharmaceutical and medical device industry.
Typically presented by Zuzanna Kwade (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
An Essential Overview of the Medical Device Industry
In-house & bespoke training
This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.
Rated by attendees to the public programme
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
In-house & bespoke training
Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.
Rated by attendees to the public programme
Typically presented by Annette Callaghan (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
In-house & bespoke training
This course will cover the key regulations used globally in human factors and usability engineering: the specific standards and guidances, methods, and the tools commonly used in medical device development.
Rated by attendees to the public programme
Typically presented by Greg Thay (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
In-house & bespoke training
Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.
Typically presented by Annette Callaghan (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
In-house & bespoke training
This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.
Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.
Rated by attendees to the public programme
Typically presented by Linda Garrod (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
An introduction to Risk Management ISO 14971:2019
In-house & bespoke training
Dive into the core principles of risk management using ISO14971:2019. Learn to assess, analyse, and mitigate risks effectively, ensuring compliance with international standards and enhancing decision-making in various industries.
Typically presented by Linda Garrod (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
An Introduction to the Design and Development of Medical Devices
In-house & bespoke training
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Rated by attendees to the public programme
Typically presented by David Howlett (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
An Introduction to the Medical Device Regulation
In-house & bespoke training
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
Rated by attendees to the public programme
Typically presented by Theresa Jeary (bio)
| Typical duration: 3 days | |
| Pricing from £1,350 per attendee | |
| Delivery: collaborative classroom |
Best Practices for Supplier Qualification in Life Science
In-house & bespoke training
Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.
Rated by attendees to the public programme
Typically presented by Mustafa Edik (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Biological Evaluation of Medical Devices
In-house & bespoke training
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.
*Includes:* Interactive workshops and discussion sessions
Rated by attendees to the public programme
Typically presented by Annette Callaghan (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Breaking the Code – Achieving Publication Success in Scientific Journals: Dealing with Reviewers' Comments and Resubmission
In-house & bespoke training
This course covers journal decision types and techniques for responding effectively to reviewers' feedback, as well as strategies for revising and resubmitting manuscripts to enhance publication success.
Typically presented by Samaa Al Tabbah (bio)
| Delivery: collaborative classroom |
Breaking the Code – Achieving Publication Success in Scientific Journals: Journal Submission and Publication
In-house & bespoke training
This course provides an overview of journal submission, including the types and steps of submissions, as well as effective pre- and post-submission communication to help participants navigate publication successfully.
Typically presented by Samaa Al Tabbah (bio)
| Delivery: collaborative classroom |
Breaking the Code – Achieving Publication Success in Scientific Journals: Selecting Your Journal
In-house & bespoke training
This session provides an essential guide to selecting both the best and authentic scientific journal for your research, offering practical strategies for using indexing systems and selector tools to enhance visibility and credibility.
Typically presented by Samaa Al Tabbah (bio)
| Delivery: collaborative classroom |
Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)
In-house & bespoke training
Master the complexities of software classification under the Medical Device Regulations (MDR), ensuring compliance and clarity with expert insights into Medical Device Coordinators Group (MDCG) guidelines. Regulatory frameworks will be discussed and practical case studies will be included (to aid the learning process).
Typically presented by Koen Cobbaert (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
Cleanroom Requirements for Medical Device Manufacturers
In-house & bespoke training
This course introduces key regulatory requirements for manufacturing sterile or clean medical devices in controlled environments. It covers standards for ensuring compliance, including environmental controls and third-party assessments.
Typically presented by Annette Callaghan (bio)
| Delivery: collaborative classroom |
Clinical Evaluation of Medical Device Software and Software as a Medical Device
In-house & bespoke training
This one-day course will provide a clear understanding of the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices.
Rated by attendees to the public programme
Typically presented by Zuzanna Kwade (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
In-house & bespoke training
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Rated by attendees to the public programme
Typically presented by Steve Curran (bio) , Joanne E Stewart (James) (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Cosmetovigilance
In-house & bespoke training
This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW).
It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.
Typically presented by Graeme Ladds (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Cyber Security for Medical Devices
In-house & bespoke training
This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.
Rated by attendees to the public programme
Typically presented by Ben Kokx (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Data Innovation for AI-enabled Medical Devices
In-house & bespoke training
This course provides an in-depth understanding of data governance for AI-enabled medical devices, focusing on European regulations like the AI Act and GDPR, ensuring compliance while fostering innovation in high-risk AI systems.
Typically presented by Koen Cobbaert (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
Deep Dive into the IVDR Annex XIII
In-house & bespoke training
Explore IVDR Annex XIII in-depth, covering Performance Evaluation, Performance Studies, and Post-market Performance. Learn what information is required, where to put it, and when, with a detailed review of nine essential documents.
Typically presented by Jane Leadsham (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW)
In-house & bespoke training
Gain essential knowledge in developing and managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW), focusing on regulatory compliance, risk management, and lifecycle management to ensure safety and effectiveness.
Typically presented by Koen Cobbaert (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
FDA Approval Process for Medical Devices
In-house & bespoke training
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.
Rated by attendees to the public programme
Typically presented by Jonathan Hughes (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Global Market Access for Medical Device Software
In-house & bespoke training
Navigate global market access for medical device software with insights on international regulations, reimbursement strategies, and Health Technology Assessment (HTA) to improve your product’s chances of commercial success
Typically presented by Catarina Carrao (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Human Factors - The Increasing Importance of Instructions for Use
In-house & bespoke training
This free webinar will focus on the often overlooked but increasingly important area of instructions for use for medical products.
Rated by attendees to the public programme
Typically presented by Greg Thay (bio)
| Delivery: collaborative classroom |
Human Factors and Usability Engineering in the Development of Drug Delivery Products
In-house & bespoke training
This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.
Rated by attendees to the public programme
Typically presented by Richard Featherstone (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Innovate: The MedTech Series – A Journey Through Innovation to an AI-Driven Future
In-house & bespoke training
This session, in partnership with Bax Innovation, will guide participants through the key phases of digital health’s evolution, showcasing real-world cases that illuminate the challenges of digital adoption.
Typically presented by David Chadima (bio) , Núria Vázquez (bio)
| Delivery: collaborative classroom |
Innovate: The MedTech Series – The 2024 EU AI Act
In-house & bespoke training
This session will summarise the EU AI Act and its implications on the healthcare sector, including how to be compliant with the new regulatory framework.
Typically presented by Cheryl Barton (bio)
| Delivery: collaborative classroom |
Interpersonal Project Management Skills for the Life Sciences Industries
In-house & bespoke training
This two-day interactive course covers the essential interpersonal skills needed to excel as a life sciences project manager.
Typically presented by Laura Brown (bio)
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
In-house & bespoke training
This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.
Rated by attendees to the public programme
Typically presented by Stuart Angell (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746)
In-house & bespoke training
Understand the essentials of performance evaluation under the In Vitro Diagnostic Regulation (2017/746) in this comprehensive seminar. Essential for regulatory compliance and business success.
Typically presented by Jane Leadsham (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)
In-house & bespoke training
Learn the critical regulatory requirements and best practices for obtaining market authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) in global markets.
Typically presented by Koen Cobbaert (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Masterclass: Market Authorisation of AI-enabled Medical Devices
In-house & bespoke training
This course provides essential guidance on navigating regulatory requirements and securing market authorisation for AI-based medical devices, covering key regulations, compliance strategies, and best practices for global market access.
Rated by attendees to the public programme
Typically presented by Koen Cobbaert (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Medical Device Regulation in the Eurasian Union, Russia and the CIS
In-house & bespoke training
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Rated by attendees to the public programme
Typically presented by Anna Harrington-Morozova (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Medical Device Regulations in Asia-Pacific Markets
In-house & bespoke training
As the Asia-Pacific market grows, new regulations emerge. Gain expert insights to navigate compliance and maximise opportunities.
Typically presented by Jack Wong (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Medical Device Regulations in the Middle East and North Africa
In-house & bespoke training
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen.
Rated by attendees to the public programme
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Medical Device Single Audit Programme (MDSAP)
In-house & bespoke training
The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.
Rated by attendees to the public programme
Typically presented by Stuart Angell (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Medical Device Studies: Clinical Evidence
In-house & bespoke training
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR.
Rated by attendees to the public programme
Typically presented by Joanne E Stewart (James) (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
In-house & bespoke training
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Rated by attendees to the public programme
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Medical Writing for Medical Devices
In-house & bespoke training
How to produce quality regulatory documents including the clinical evaluation report (CER).
Rated by attendees to the public programme
Typically presented by Barbara Grossman (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Metered Dose Inhaler (MDI) Technology
In-house & bespoke training
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Rated by attendees to the public programme
Typically presented by David Howlett (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products
In-house & bespoke training
Gain practical guidance on EU and FDA regulations for drug/device combination products, along with solutions to current challenges, in this comprehensive course.
Rated by attendees to the public programme
Typically presented by
Tina Amini (bio)
and 3 more leading experts
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
Navigating Regulatory Compliance Whilst Developing and Distributing Polymerase Chain Reaction (PCR)-Based IVD Tests
In-house & bespoke training
In this three-hour course, learn from an expert about developing and distributing PCR-based IVD tests, as well as exploring the latest regulatory requirements.
Typically presented by Dmitriy Kosarikov (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
Non-Conformance and Corrective Action for Medical Device Manufacturers
In-house & bespoke training
The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.
Rated by attendees to the public programme
Typically presented by Annette Callaghan (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
Post-Market Surveillance - Practical Application for Medical Devices and IVDs
In-house & bespoke training
In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.
Rated by attendees to the public programme
Typically presented by Anne Jury (bio) , Karen Pearson (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Post-Market Surveillance and Vigilance of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)
In-house & bespoke training
Learn the essential regulatory requirements for post-market surveillance (PMS), post-market clinical follow-up (PMCF), and vigilance of digital health technologies, ensuring product safety, compliance, and continued value creation throughout the product lifecycle
Typically presented by Catarina Carrao (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Practical Implementation of a Human Factors Study
In-house & bespoke training
This training focuses on the practical and logistical aspects of planning, preparing and performing human factors studies for medical devices and combination products.
Typically presented by Richard Featherstone (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Pre-Filled Syringes: End-to-End Processing
In-house & bespoke training
Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
Rated by attendees to the public programme
Typically presented by Dale Charlton (bio) , Susanne Hall (bio) , Andreas Rothmund (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Process Validation for Medical Devices
In-house & bespoke training
This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.
Typically presented by Mustafa Edik (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Smart Packaging and Electronic Patient Information
In-house & bespoke training
This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives.
Rated by attendees to the public programme
Typically presented by Graham Howieson (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Sterilization of Medical Devices
In-house & bespoke training
Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
Rated by attendees to the public programme
Typically presented by Annette Callaghan (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Sustainable Design and Manufacture for Medical Devices
In-house & bespoke training
Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This free webinar will give you a high level of understanding of what sustainability options exist, what the benefits are and what drives them.
Rated by attendees to the public programme
Typically presented by Cormac O'Prey (bio)
| Delivery: collaborative classroom |
Sustainable Design and Manufacture for Medical Devices
In-house & bespoke training
This seminar will give you an in-depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company.
Rated by attendees to the public programme
Typically presented by Cormac O'Prey (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
The Future of Manufacturing: 3D Printing for Medical Devices
In-house & bespoke training
This course will help you understand future manufacturing of medical devices using 3D printing technology. Anyone from the medical device, additive manufacturing and pharmaceutical industries will benefit.
Typically presented by Ruchi Pathak (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
In-house & bespoke training
This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
Rated by attendees to the public programme
Typically presented by Stuart Angell (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
UK Conformity Assessed (UKCA) Marking for Medical Devices
In-house & bespoke training
This course provides UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK.
Rated by attendees to the public programme
Typically presented by Tina Amini (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
In-house & bespoke training
The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.
Rated by attendees to the public programme
Typically presented by Annette Callaghan (bio)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |