Medical Device Startups
I am sympathetic to the challenge of startup companies and provide thorough audits to prepare companies for stage 1 and stage 2 certification audits and beyond. I appreciate that it is often easier for external auditors to highlight and resolve concerns before visits by regulators and notified bodies. My support begins with a line-by-line review and discussion of your company procedures against applicable regulations and standards requirements. My extensive experience enables me to suggest options appropriate to a start up company. The combination of my 20+ years of industry experience and my role as a trainer allows me to provide examples of what works well. Where helpful, I explain my rationale behind my audit questions, including showing the auditee the specific section of the specification, standard or regulation.
Software as a medical device (SaMD) and Software in a medical device (SiMD) are the two main types of medical software reshaping the medical device sector and have the potential to benefit millions of people's lives. Medical device software manufacturers must define and document the design and development process, and notified bodies check these requirements.
I have supported startups designing and developing SiMD and SaMD (medical device wearables) through their ISO 13485:2016 stage 1 and stage 2 certification audits. One of the biggest challenges for start-ups is providing the documentation and records required to satisfy the requirements of standards and regulations such as FDA 21 CFR section 820.30, ISO 13485 section 7.3, ISO 14971:2019 and IEC 62304:2006 + AMD1:2015.