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

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.

Typically presented by Annette Callaghan (bio)

Typical duration: 4 days
Delivery: collaborative classroom

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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 4 more leading experts

Typical duration: 2 days
Pricing from £1,299 per attendee
Delivery: collaborative classroom

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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 Janette Benaddi (bio) , Theresa Jeary (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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

Typically presented by Theresa Jeary (bio) , David Jefferys (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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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.

Typically presented by Annette Callaghan (bio)

Delivery: collaborative classroom

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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 that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.

Typically presented by Greg Thay (bio)

Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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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.

Typically presented by Stuart Angell (bio)

Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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 Janette Benaddi (bio) , Will Burton (bio) , Theresa Jeary (bio)

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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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.

Typically presented by Mustafa Edik (bio)

Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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Clinical Evaluation of Medical Device Software

In-house & bespoke training

This 1-day course will provide a clear understanding of the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices.

Typically presented by Zuzanna Kwade (bio)

Delivery: collaborative classroom

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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 Janette Benaddi (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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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: 1 day
Pricing from £800 per attendee
Delivery: collaborative classroom

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Delivery of Biologics to the Nasal Cavity

In-house & bespoke training

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

Rated by attendees to the public programme

Typically presented by Gemma Budd (bio)
and 3 more leading experts

Typical duration: 4 days
Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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. From the perspective of human factors and usability engineering, Instructions for Use significantly impact the performance of the user to use medical devices safely and effectively and often are only used when the user has a problem. The webinar will look at why we need Instructions for Use to be usable, not only for safety but for regulatory approval and how you achieve that. It will address what predictions can be made from existing data and discuss what the future of Instructions for Use could be.
This is an excellent opportunity to learn more about this important element of your regulatory submission.

Rated by attendees to the public programme

Typically presented by Greg Thay (bio)

Typical duration: 90 days
Delivery: collaborative classroom

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Human Factors and Usability Engineering in the Development of Drug Delivery Products

In-house & bespoke training

Applying HF and usability to comply with the MDR.

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 £800 per attendee
Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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Managing Competence within the Medical Device Industry

In-house & bespoke training

This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.

Typically presented by Anne Jury (bio)

Delivery: collaborative classroom

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Masterclass: Artificial Intelligence-based Medical Devices

In-house & bespoke training

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust and to ensure data is portable and qualitative. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

Rated by attendees to the public programme

Typically presented by Koen Cobbaert (bio)

Typical duration: 3 days
Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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

Typically presented by Heba Hashem (bio) , Ilona Putz (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

In-house & bespoke training

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Rated by attendees to the public programme

Typically presented by Koen Cobbaert (bio) , Zuzanna Kwade (bio)

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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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 Janette Benaddi (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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

Typically presented by Janette Benaddi (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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 Janette Benaddi (bio) , Barbara Grossman (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products

In-house & bespoke training

Practical guidance complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products 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

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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.

Typically presented by Annette Callaghan (bio)

Typical duration: 4 days
Delivery: collaborative classroom

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Post-Market Surveillance - Practical Application for Medical Devices and IVDs

In-house & bespoke training

Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system.
This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities.

Typically presented by Anne Jury (bio) , Karen Pearson (bio)

Typical duration: 1 day
Delivery: collaborative classroom

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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 £800 per attendee
Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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Smart Packaging and Electronic Patient Information

In-house & bespoke training

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). 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, providing insight as to where organisations may be most significantly impacted.

Rated by attendees to the public programme

Typically presented by Graham Howieson (bio)

Delivery: collaborative classroom

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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)

Delivery: collaborative classroom

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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

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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 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. It will also provide practical advice on how to implement change.

Rated by attendees to the public programme

Typically presented by Cormac O'Prey (bio)

Delivery: collaborative classroom

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The Medical Device School - From Concept to CE Marking

In-house & bespoke training

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Rated by attendees to the public programme

Typically presented by Stuart Angell (bio)
and 7 more leading experts

Typical duration: 5 days
Pricing from £1,500 per attendee
Delivery: collaborative classroom

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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.

Typically presented by Stuart Angell (bio)

Delivery: collaborative classroom

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UK Conformity Assessed (UKCA) Marking for Medical Devices

In-house & bespoke training

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.
This seminar will provide 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 after June 2023.

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio)

Delivery: collaborative classroom

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Content was informative and thought provoking. A great introduction into the potential management of smart packaging projects and programs and the ways in which this could positively impact business and patients.

Pamela Nagel-Kotze, Senior Regulatory Associate, Rosemont Pharmaceuticals LTD

Janette and Barbara were both great! Very knowledgeable, personable, enthusiastic, friendly, and with fantastic presentation skills.

Kiara Batten, Senior Clinical Trial Manager, Odin Vision

Koen has a breadth and depth of experience in this area, and was great at sharing that in an very accessible manner.

Michelle Galea, External Projects Manager, Optos plc

I am brand new to the CER world and was hoping to better understand the layout. Janette did a fantastic job helping me to accomplish this. She made it very easy to get a clear picture of the expectations of completing a CER.

Tena Green, Medical Writer/Clinical Consultant, SunMed LLC

Very kind and attentive

Nicolas Oviedo, Medical Affairs Specialist, Baxter Healthcare Corp

It was very organized and beautifully presented

Tena Green, Medical Writer/Clinical Consultant, SunMed, LLC

I thoroughly enjoyed the webinar, particularly for its interactive elements. The Q&A sessions, practice opportunities, and Pop quizzes were highlights for me, enhancing the learning experience by encouraging engagement and providing real-time feedback. These interactive parts not only made the content more relatable but also allowed for a deeper understanding of the topics discussed. The presentation was clear and well-structured, and the speakers demonstrated extensive knowledge and passion for their subject matter.

Lloyd Nunag, Clinical Trial Manager, Odin Vision

That is was so interactive - we could always ask and the presenters always has good examples from the real world to illustrate their point.
Interaction with the other course participants was also really and useful.
It was particularly useful for me to get input to some of the CER content: claims, CDP etc.

Linda Lerdrup, Clinical Scientific Manager, UNEEG medical

My goal was to gain an overview on the regulations on medical devices and the general procedure of clinical evaluations. This goal has been achieved.

Hoda Bazafkan, Clinical Evaluations Manager, Geräte GmbH

The training was clear and comprehensive.

Alexandre Jauniaux, Head of division, Federal Agency for Medicines and Health Products