Hi, I'm Sharon
I serve as the quality and regulatory manager for medical device companies working on software and active devices, or work alongside the QA/RA manager you already have. I build or improve the quality system, take the product through to registration, and stay with you afterwards. People call me with the hard questions, and I know how to balance what the company needs with what the regulations require.
How do you turn an innovative medical idea into a safe, approved product that's ready for the market? That's where I come in.
I've been in your shoes. In 2005 I joined CDP Medical, where I ran quality, regulatory and operations, which also meant imports, orders and keeping the office running. When Philips Healthcare bought the company in 2010, I stayed on as senior manager for quality and regulatory. I harmonized the quality system across the business unit and got products approved in the US, Europe, Australia, Asia, Latin America and Russia.
From 2014 to 2019 I was on the management team of Physio-Logic, a regulatory consulting company, where I led approval programs from concept to clearance for companies such as Philips, Biosense Webster and Insightec. I then went back in-house for two years as Director of QA/RA at BeamMed, and in 2020 I founded qualityworks.
So I know both sides of the table. I know what it's like to be the person inside the company who has to keep the system running, and what it's like to come in from outside and find the gaps.
I work on quality and regulatory together, not one or the other. That matters more than it sounds, because the quality system and the regulatory file have to tell the same story, and the auditor will check that they do.
Alongside client work, I build tools such as quality.navigator, which helps QA/RA people think through everyday decisions. I also write the qualitypulse. blog and create training in Hebrew and English.
I'm an ISO 13485:2016 Lead Auditor (BSI), BSI-trained in MDR implementation for CE marking, a Certified Manager of Quality/Organizational Excellence (CMQ/OE) and a Six Sigma Green Belt.
Over 20 years in medical devices
My values
I keep an open dialogue and a positive attitude, and when a project needs it, I team up with other great partners. We combine our knowledge and expertise to deliver what I promised.
I bring hands-on, practical experience and deliver quality work, focused on results and on seeing things through. I'm committed to honesty, trust and transparency, and I do the right thing even when no one is watching.
I take my work seriously and aim for exceptional results in every project, so you can get safe medical devices to your patients and users. I bring an outside perspective to get past obstacles, and I find solutions together with you.
I love what I do, and I do it with love. I keep learning, improving and staying current, so the service you get is anything but basic.
Working as one team
Doing what's right
Seeing it through
Loving what I do
Who my services are right for
My work focuses on medical device companies whose products include software, SaMD or active devices.
I serve as your quality and regulatory manager on a part-time basis, with the same responsibility the role carries.
I work alongside the QA/RA manager you already have, when there is more work than one person can carry or when they want a senior person to think with.
I build or improve the quality system and take the product through to registration under ISO 13485, EU MDR, FDA QMSR and MDSAP.
Audits, complaints, changes and reports continue after certification. I stay with you and keep the system working between audits.
When your QA/RA manager is on maternity leave or reserve duty, I step in and keep the work moving until they return.
You want someone who tells you where you stand and balances what the company needs with what the regulations require.
You develop software or an active device
You need a QA/RA manager, but not a full-time hire
Your QA/RA manager needs a partner
You are on the way to your first certification
You are certified, and the work keeps coming
Your QA/RA manager is away for a while
You want clear answers to the hard questions
Who my services are not right for
I'm a partner who works with you part-time, not an employee. If you need someone in-house, on-site, five days a week - this isn't the right model. If you need senior QA/RA expertise on a flexible, scalable basis, it is.
If the goal is to check a box for an investor deck or pass a single audit with no intention of maintaining the system - I'm not the right partner. I build real systems that hold up under scrutiny.
My job is to tell you where you stand, what the risk is, and what needs to change. That's not always comfortable, but it's what protects you in an audit.
I don't specialize in these areas and won't take on projects where they're central to the compliance scope. But I know excellent consultants that can help with that - so call me.
These are outside my scope. I work on QMS and regulatory compliance, not the clinical side of the technical file. But I know great people who do - so call me.
I don't serve as an Authorized Representative, Importer, or Distributor under EU MDR or other frameworks. These are legal entity obligations that require a registered presence, not a consulting engagement.
I don't take on the PRRC role under EU MDR Article 15 as an outside person. I work with the PRRC you appoint and make sure they have what they need to do the job.
You need a full-time employee
You want QA/RA on paper, not in practice
You want someone who will just tell you what you want to hear
Your device involves sterilization or cleanroom manufacturing as a primary focus
You need clinical evaluation or PMCF support
You need Economic Operator or Authorized Representative services
You need an external PRRC
A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.