about qualityworks.
about me
Hi, I'm Sharon.
I help med-tech companies launch safe, innovative devices – faster.
With 20+ years of experience in Quality and Regulatory Affairs, I’ve helped 40+ medical device companies successfully bring their innovations to market. From startups to global manufacturers – I’m here to simplify complex regulation, guide smart strategies, and make quality work for you.
Need a trusted regulatory partner?
my approach to quality
I believe that quality is more than just compliance - it’s the foundation of safe and effective medical devices. My approach focuses on creating efficient, results-driven processes that not only meet regulatory standards but also improve workflow and product safety.
Through internal audits, supplier evaluations, and strategic risk management, I identify gaps early and help companies implement smart, sustainable solutions to maintain compliance and operational excellence.
what I offer
- Regulatory strategy – EU MDR & FDA 510(k)
- Technical writing and TD compilation – TF, DHF, DMR
- QMS development – ISO 13485, FDA QSMR, EU MDR, MDSAP
- Audit/inspection readiness – MDSAP, FDA, CE, ISO 13485
- Audit management - Internal and suppliers
- CAPA, complaints, and remediation
- Team training & mentoring
achievements.
achievements
I believe that good work speaks for itself. These achievements reflect the trust companies have placed in me — and the outcomes we’ve reached together.
From CE Marking under MDR to FDA clearances and ISO certifications, I’ve been proud to help innovative med-tech companies succeed.
FDA
Took part and collaborated on various FDA 510(k) submissions, including complex devices like wearables, laparoscopes, and diagnostic imaging systems. Devices include: ChroniSense Polso Watch (K220351), Sanolla VoqX (K212709), 270Surgical SurroundScope (K210104), and more.
EU MDR
Led MDD to MDR Transition projects: Image Navigation's guided implantology system, Sofwave's aesthetic system, BeamMed's bone density system.
Took part and collaborated in numerous technical file submissions, from Class I to Class III devices, including Newsight Imaging's SpectraLIT, Lithotech medical's Urolith, Image Navigation's IGI, Pi-Cardia's ShortCut, and many more.
MDSAP
Managed MDSAP readiness projects for companies like Tyto Care, PriGen and Sofwave, including full QMS remediation and audit preparation.
quality management system
Guided numerous companies through full ISO 13485 certification – from QMS setup to successful audit. Examples: Leviticus Cardio, Renal Dynamics, Physio-Logic, CDP Medical.
Led harmonization efforts across global operations and multi-site systems – improving QMS alignment at CDP Medical and PriGen.
Upgraded numerous Quality Management Systems over the years.
other achievements
Directed remediation programs for Philips Healthcare, leading large-scale QMS improvement initiatives across product lifecycle and audit functions.
Educator & Communicator – Published professional articles on qualityworks blog and taught QA/RA topics at Tel Aviv University.
curious about how these results came to life?
working together.
collaborate with trust and positivity.
doing the right work.
hands-on, practical, and honest execution.
getting work done.
results-driven, solution-focused
loving my work.
passion + continuous learning = true quality