Thank you for visiting CHIARA’s website. My name is Lesley Paice and I’m a biochemistry graduate with over 25 years of experience working in the medical device industry starting my career in research and development before moving into Regulatory Affairs and later Quality Management. I have worked in a number of different medical device companies ranging from start-ups to multi-national companies in various positions up to Regional Director level.
I have experience of the development, validation, manufacture and registration of a range of in vitro diagnostic medical device tests covering all classifications under the IVDD. This has included Annex II List A blood grouping reagents and HIV tests, an Annex II List B chlamydia test and a wide range of different women’s health, infectious disease, drugs of abuse and cardiac marker tests.
I also have experience of the development, manufacture, validation and registration of Class IIb and Class III sodium hyaluronate based products suitable for use in orthopaedic, ophthalmic and aesthetic indications. I have experience with successful 510(k) submissions as well as submission of both product and facility Biologics License applications to the FDA. I have also participated in a number of successful FDA inspections.
With the dramatically changing regulatory environment, it is much harder for manufacturers to bring medical device products to market and more important for them to have access to regulatory expertise. I recognised the specific need for RA and QA consultancy support to assist in the understanding and implementation of regulatory requirements. In my experience, small start-up organisations often feel overwhelmed with the RA and QA environment they find themselves in. As a result, I founded CHIARA in June 2016 and have been supporting a number of different medical device companies providing regulatory, quality and clinical support. This has ranged from small start-up organisations to larger well-established manufacturing organisations. Furthermore, I carry out Class III expert reviews for a Notified Body giving me an excellent insight into what the regulator is looking for.
If you think CHIARA could assist you then please contact me here.