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In-house & bespoke training:
Medical Devices

The constant development of new medical devices, alongside changes and updates to regulations are paramount to this ever-changing and highly diverse field. Whether you are looking to develop your understanding of combination products, dry powder inhalers, FDA processes or would like to learn about how to write and edit medical writings, Management Forum offers a wide selection of medical device industry training courses for you to keep up with and understand the changes and specialities of Medical Devices.

With over a hundred expert speakers, we deliver training that is highly interactive and offers a great opportunity for you to network with others working in the medical device industry. Find the medical device training course that best suits your needs or contact us to find out more.

 

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 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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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 Michelle Kelly (bio) , Jeremy Tinkler (bio)

Typical duration: 2 days
Pricing from £800 per attendee
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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Cyber Security for Medical Devices

In-house & bespoke training

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. 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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Drug/Device and Device/Drug Combinations in the EU and USA

In-house & bespoke training

Practical guidance on borderline Issues and combination products

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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EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers

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. 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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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 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) , Nancy Consterdine (bio)

Typical duration: 2 days
Pricing from £800 per attendee
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.

Typically presented by Eamonn Hoxey (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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New Regulations for Medical Devices and IVDs in Europe

In-house & bespoke training

During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.

Rated by attendees to the public programme

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

Typical duration: 2 days
Pricing from £800 per attendee
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) , Andreas Rothmund (bio)

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

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Quality Management Refresher

In-house & bespoke training

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management.
It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

Typically presented by Rob Hughes (bio)

Typical duration: 1 day
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.

Typically presented by Christopher Waterhouse (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.

Typically presented by Eamonn Hoxey (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.

Typically presented by Cormac O'Prey (bio)

Delivery: collaborative classroom

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Technical Documentation to Comply with the MDR and IVDR

In-house & bespoke training

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

Rated by attendees to the public programme

Typically presented by Will Burton (bio) , Paul Sim (bio)

Typical duration: 2 days
Pricing from £800 per attendee
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 Janette Benaddi (bio)

Typical duration: 5 days
Pricing from £1,500 per attendee
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.

Typically presented by Janette Benaddi (bio)

Delivery: collaborative classroom

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Mr. Howlett was very forthcoming, open to questions, and he really poured his expertise in the training, which made all the difference... I liked a lot the first day about design and development, of which I did not know anything.

Christian Micheletti, RA Manager, Nouvag AG

It was very good, I was impressed, I would have loved to do this course in person but this was a good alternative.
The speakers were very good, very knowledgeable but also good at teaching/ relating information. The presentations were easy to follow, it was useful to have the documents there to follow along as the speakers talked. All the content was relevant to the topic and occasional humus.

I enjoyed the course and would recommend Management Forum to my colleagues.

Zhané Healey, Senior Laboratory Technician, Medical Engineering Technologies

Absolutely fantastic. I needed to be able to communicate more effectively with my Regulatory colleagues and I believe the information I have learned on this course will assist me to do that

Jenny Ramsey, Quality Engineer - Compliance, Pfizer R&D UK Ltd

Great presenter, great content. It's clear that Koen has extensive and very relevant experience in the field. He's an engaging presenter with useful insights.

Michelle Galea, External Projects Manager, Optos plc

I would recommend it to anyone with no experience of design controlled medical device development. A good overview with a good amount of detail.

Hugh Clark, Mechanical Engineer, Cambridge Design Partnership

Good pace. Mixture of text and graphics... David did a good job and was engaging considering that the course was online, which is always difficult.

Danny Kendall, Senior Physicist, Elekta Ltd

All was great, no complaints!

Angelica Morreno, Regulatory Affairs Assistant, Sinclair Pharmaceuticals

I was hoping to get more information regarding 510(k) submissions. I am very happy that I got the opportunity to learn much more. I learned a lot and feel more confident about my understanding of the submission processes.

Natale Rolim, Project Manager, EpiGuard

I was happy to attend to this webinar and it was really useful and well-explained and organized.

Mireia Crosa, Regulatory and Compliance Specialist, Diagnostic Grifols, S.A.

Excellent - speakers were very, very knowledgeable, kept things interesting, lots of opportunity for questions..

Róisín Byrne, Senior Regulatory Affairs Officer, Ayrton Saunders Limited