Our latest COVID-19 information/status - including self-paced online learning from our training partner Falconbury

Training & Courses:
Development and technology

Technology and innovation in the medical device industry is constantly changing, from innovation in products, improving existing products to manufacturing processes and modes of practice. Our training courses will provide delegates with essential information and illustrate the opportunities available from the use of medical device software to artificial intelligence and more.

 

Our spring/summer 2020 programme of London-based courses has been cancelled due to the COVID-19 outbreak. We are taking bookings for our Autumn events, but we are also working to deliver courses and content online. Please contact us if you are interested in an on-site or online version of any of our courses, tailored to your company's needs.

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

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

Biological Evaluation of Medical Devices

25-26 Nov 2020

Also on: 18 May 2021

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Practical guidance on borderline Issues and combination products

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

FULLY UPDATED PROGRAMME

Dry Powder Inhalers

23-24 Jun 2021

The ‘how to’ of technology transfer across the product lifecycle

Effective Technology Transfer

1-2 Oct 2020

Also on: 20 Apr 2021

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.

An essential annual update for inhalation professionals.

Inhaled Drug Delivery

3-4 Nov 2020

Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.

Injectable Drug Delivery

10-11 Mar 2021

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

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Metered Dose Inhaler (MDI) Technology

16-17 Sep 2020

Also on: 16 Feb 2021

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Nasal Drug Delivery

15-16 Apr 2021

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.

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.

Technical Documentation to Comply with the MDR and IVDR

29-30 Sep 2020

Also on: 10 Mar 2021

A practical five-day course with interactive workshops – now in its 17th successful year!

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.

I learned a lot and got some great insights into the process of design and development. It is an intense course with a lot of ground covered.

Damien Tackney, Reg Affairs, Ovelle Ltd

Both very good and enthusiastic speakers. It is very nice that they work with MDSW and have a lot of examples, which makes it more understandable. I liked the course and learned a lot.

Jennie Mettivier Meijer, Project Manager Medical Devices & Quality Systems, BioTop Medical

The course was absolutely great and to get helpful advice from the experienced speaker was fantastic.

Ulrike Ratz, CMC Manager, Cheplapharm Arzneimittel GmbH

I learned a lot from this course, the speakers were great and they encouraged questions from the attendees. The quiz summarized each part well. My overall opinion is very positive and I would recommend it to my colleagues.

Avital Levertov, Regulatory Affairs Manager, Elcam Medical ACAL

I was hoping for further improvement of my understanding of the matter of inhalational drugs, especially MDI, and this expectation was fully met. The speakers had superb knowledge of the subject, vast experience and a great sense of humour.

Robin Boehm, Team Leader Regulatory Submissions - New Products, STADA Arzneimittel AG

The course accurately met my expectations with regard to content and quality – it was very good!

Brennan Miles, Senior Consultant, Team Consulting

All my expectations were met, including good venue and excellent organization! It was great to have so many expert speakers from regulatory agencies and notified bodies, which always makes a big difference. I particularly liked the competence of the speakers and their willingness to answer participants' questions, that it was a very interactive course, and that we received hard copies of the presentations.

Beate Schmidt, Consultant Regulatory Affairs, benefits Regulatory Consulting

Great overall. All topics of design control were covered well and I think everyone left with a better understanding than when they arrived. I have definitely applied some of the lessons we learned to my current role.

Emma Fairhall, R&D Manager, Leica Biosystems

It was a good course with good shared discussion about many topics and issues. The course material was well organized.

Elen Lasri, Regulatory Affairs Specialist, Elcam Medical ACAL

I am very satisfied with the course. I learnt a lot and the subject of HFE studies is much clearer to me. We were able to have very good discussions with the speaker who seemed to be very knowledgeable.

Nina Bladh, Director CMC Regulatory Affairs, Camurus AB