Your quality and regulatory manager, without a full-time hire
I work with medical device companies. I build or improve the quality system, take the product through to registration, and stay with you afterwards.
Your partner in medical device quality and regulatory affairs
I also build regulatory tools and certificate courses for quality and regulatory teams, and you will find all of them here on the site.
Among the companies I've worked with: Sofwave, Inovytec, 270Surgical, Commwell Medical, Sanolla, Nanox Imaging, BeamMed, Image Navigation, Newsight Imaging, Chronisense, Rimed, and Pi-Cardia.
Sharon Resnick
Over 20 years, more than 30 medical device companies
Pick the one closest to where you are, and I'll show you how I can help.
Pick the situation closest to yours
Building the quality system and the technical file
Notified body, FDA, MDSAP or an important client
CAPA, a 483 or a warning letter
QMSR, MDR, new standards
Before first certification
Upcoming audit
After findings
Something is changing
QMS setup and upgrade
Regulatory strategy and registration
Software and SaMD
Risk management and CAPA
PMS and vigilance
Audits
Remediation after findings
Regulatory change projects
Change control and ECOs
Controlled use of AI in the QMS
Training and mentoring
How I can help
Quality system
Regulation and registration
Post-market
Audits and training
Read about this service
I serve as your quality and regulatory manager or support the manager you already have, including when that manager is away for a while.
Ongoing QA/RA
Answers to everyday regulatory questions
Apps I build
Regulatory deadlines in the EU and the US, conferences and notified body events, each with its official source.
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USA · FDA
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EU · MDR
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EU · AI Act
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From the first conversation to a steady work rhythm
You tell me about the device, the company and what is worrying you.
If needed, I review your quality management system and documentation to see where you stand.
I scope the work and send you the estimated hours and timeline in writing.
We do the work together, and then keep a steady monthly rhythm.
A first call
A look at what you have
A clear proposal
The work, then a rhythm
I have over 20 years in medical devices, first inside companies, including Philips as a senior manager for quality and regulatory affairs, and then more than 10 years working alongside them. People come to me with the hard questions, and I know how to balance what the company needs with what the regulation requires.
Hi, I'm Sharon
I work by four values: working as one team with you, doing what's right even when no one is watching, seeing every project through, and loving what I do.
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Questions people ask first
In a 30-minute call, you tell me where you stand, and I tell you what I'd do first and whether I'm the right fit.