Medical Device Startups

I help startups successfully navigate Stage 1 and Stage 2 certification by identifying and resolving compliance gaps before notified bodies arrive. My process features a line-by-line review of your operating procedures against strict regulatory standards. Leveraging 25+ years of industry experience and a background in training, I provide practical examples of what works while steering you away from common pitfalls. Every question I ask comes with a clear explanation and direct reference to the applicable standard, ensuring your team learns throughout the process.

Startups need rigorous preparation without operational strain. My extensive background allows me to provide practical, right-sized compliance strategies. Clients describe these assessments as far more thorough than official notified body audits. Plus, the scheduling is completely flexible, allowing us to split the agenda into half-day intervals over several days.

“As a start-up medical device company, Isovasc Medical found Anne Marie from Limehill Quality Solutions to be an excellent partner to work with. We engaged Anne Marie to carry out an internal audit of our Quality Management System in preparation for our initial BSI ISO 13485 certification audits.

"Anne Marie conducted a thorough and comprehensive audit, providing valuable insight into our readiness for the Stage 1 and Stage 2 certification audits. Her expertise in ISO 13485, the Medical Device Regulation (MDR), and medical device quality systems enabled her to identify deficiencies and areas for improvement within our QMS before the external audits. Addressing these issues in advance contributed to a smooth certification process.

She has an excellent understanding of ISO 13485 and MDR requirements and communicates audit findings and regulatory expectations in a clear and practical way. Her professionalism, attention to detail, and thoroughness were invaluable throughout the process.

Isovasc Medical would have no hesitation in recommending Anne Marie and Limehill Quality Solutions to any medical device company, particularly start-ups preparing for ISO 13485 certification or MDR compliance. We look forward to continuing to work with Anne Marie and Limehill Quality Solutions as a trusted partner for future audits and quality and regulatory projects"  Eoin McEvoy, IsoVasc Medical

SaMD & SiMD

Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) including medical wearables are revolutionising healthcare and improving millions of lives. For manufacturers, establishing a clearly defined and documented design and development process is critical, as notified bodies audit these frameworks meticulously.
Having guided numerous startups through successful ISO 13485:2016 Stage 1 and Stage 2 certification audits, I understand the unique hurdles early-stage companies face. One of the greatest challenges is compiling the rigorous documentation and technical records needed to satisfy stringent global standards. I specialise in bridging this gap, ensuring your files completely align with FDA 21 CFR Part 820.30, ISO 13485 (Section 7.3), ISO 14971:2019, and IEC 62304:2006 + AMD1:2015.
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