Hi I’m Shal – author of Life of Shal and founder of Scientist’s Sanctuary – a Science and Medical Device Compliance Resource company.
I’ve authored a range of medical device eBooks and recently started creating simple easy-to-use templates to help medical device manufacturers ensure regulatory compliance.
Contact me directly for more information on available resources.
Regulatory compliance of medical devices doesn’t have to be hard. All you need is to understand what the regulations are asking you for.
I’d love to help you on your regulatory compliance journey!
During the last four years I’ve gained a wealth of experience with the following standards and medical device regulations:
- ISO 13485, ISO 11135, ISO 11137, ISO 10993
- Medical Device Directive (MDD 93/42/EEC)
- Medical Device Regulation (MDR 2017/745)
- South African Medical Device Legislation (SAMDL)
- 21 CFR 820
I’ve created simple easy to use templates to help manufacturers build their technical file chapter by chapter. These templates include clinical evaluation plans and reports, biocompatibility reports and essential requirements. Contact me for a full list of resources available.
Understanding medical device regulations can be tricky at times. Trust me, I know! So I came up with the idea of creating a series of books geared towards newbies to the industry. Learn about the history of the regulations, how to successfully carry out your MDR transition and how biocompatibility testing works.
Browse some of my medical device compliance resources and eBooks below!
I purchased the General Safety and Performance Requirements template from Scientists Sanctuary… it was easy to download and had comments and prompts which made it easy to complete!