Meet...

Annette Callaghan

Presenter

A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).

Annette Callaghan’s courses

  • 02 Oct • 2 day course

Advanced Regulatory Affairs for Medical Devices

Live online

  • 16 Oct • 2 day course

Sterilization of Medical Devices

Live online

  • 03 Nov • 3 day course

An Introduction to the Medical Device Regulation

Live online

  • 21 Jan • 2 day course

Biological Evaluation of Medical Devices

Live online

  • 23 Feb • 1 day course

Cleanroom Requirements for Medical Device Manufacturers

New for 2026

Live online

Reviews for Annette’s courses

This was an excellent webinar. Very useful and [speaker] has a lot of knowledge and experience, giving us examples from real life, making the concepts easier to understand and the course more enjoyable, was fantastic - kept me engaged the entire time. Very well organized.

3 Feb 2025

Sterilization of Medical Devices

The course provided valuable insights and practical examples that clarified complex concepts. I particularly appreciated the detailed explanations of the ISO 10993, and the practical cases-workshops. Clear, well-structured with a very experienced and professional speaker. Thank you!

15 Jan 2025

Biological Evaluation of Medical Devices

The course was informative and helpful. The content was exhaustive and touched all the aspects of Biocompatibility. Really loved the presenter [who] made the course fun and easy to understand. Speed was perfect for me to follow along, and [it] certainly gave me the confidence to be able to provide support to my product development team.

15 Jan 2025

Biological Evaluation of Medical Devices

Content, speaker and presentation were all of a high standard and I came away with a much better understanding of biocompatibility / biological evaluation. The content on chemical characterization was particularly helpful. I was overall very happy with this training course.

15 Jan 2025

Biological Evaluation of Medical Devices

[My goal was to gain] a comprehensive view of the nonconformities management process and facing it from different perspectives. It was accomplished by this course. [Speaker] was exhaustive in the topic; interactive; she enriched the webinar with a lot of useful examples.

12 Dec 2024

Non-Conformance and Corrective Action for Medical Device Manufacturers

Excellent - very informative and managed to pack a lot into a half day training session. I thought [speaker] was a great presenter and clearly had deep knowledge of the subject matter.

11 Nov 2024

An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

[Speaker] very experienced, knowledgeable and approachable. Webinar [was] prepared taking into account all of the participants with the general information as well as with the direct individual requirements in mind. Questions answered at the time as well as within time given after the webinar. Thank you.

17 Oct 2024

Sterilization of Medical Devices

The Speaker was very knowledgeable and the inside stories are great!

6 Jun 2024

Sterilization of Medical Devices

There was a lot of useful information within the webinar and I learnt some new things, the programme was very well managed and presented to us very well. Annette did a great job!

4 Jun 2024

Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers

The webinar was presented very well with both speakers having a clear understanding of the changes and implications that the MDR will have. Both speakers were able to help with all questions with a clear understanding of their answers and applicability. Both speakers were very clear and very helpful with all questions and all parts were very informative, i really liked the workshops.

6 Nov 2023

An Introduction to the Medical Device Regulation

Annette’s blog posts