about qualityworks.
experience you can count on
With over 20 years of expertise in Quality and Regulatory Affairs, including more than a decade as an independent consultant, I help medical device companies navigate the complex path from product development to market approval.
Unlike many consultants who focus solely on quality or regulatory, I specialize in both—ensuring a seamless, integrated approach to compliance, risk management, and market readiness. My experience spans global corporations and fast-paced startups, giving me a unique ability to tailor solutions that fit each company’s needs—whether it’s scaling quality processes efficiently or ensuring regulatory approvals without delays.
I have worked extensively with both software-based medical devices (SaMD) and hardware-software integrated solutions, ensuring that quality and regulatory requirements align with product development from the start.
proven results and strategic guidance
Throughout my career, I have helped companies:
- Successfully pass FDA, CE, and ISO 13485 audits with zero critical findings
- Implement scalable QMS solutions that support both early-stage startups and established companies
- Develop Technical Files, DHF, and DMR documentation that meet the most stringent regulatory expectations
- Identify and mitigate risks early, preventing costly remediation efforts post-audit
- Conduct internal audits, supplier audits, and strategic risk management to ensure regulatory readiness
practical and strategic 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.
collaboration, training and leadership
Quality and regulatory success isn’t just about processes - it’s about people. I work closely with leadership teams, providing training and mentorship to empower employees, foster cross-departmental collaboration, and ensure teams are equipped to handle compliance with confidence.
I also support companies in preparing technical and regulatory documentation, ensuring every submission meets industry and regulatory expectations.
tailored solutions, proven results
No two companies are the same, and neither are their regulatory challenges. I work closely with my clients to develop customized action plans, designed to address their specific organizational needs and accelerate their path to market.
If you’re looking for a strategic partner who can help you streamline compliance, optimize your QMS, and navigate regulatory approvals with confidence - let’s connect.
Sharon Resnick, QA/RA Expert
our values
working together.
doing the right work.
doing the right work.
We have open dialogues, a positive attitude and we team up to success with other great partners, leveraging each other's knowledge, competence and expertise to provide our comprehensive services as promised.
doing the right work.
doing the right work.
doing the right work.
With our hands-on practical experience, we deliver quality services to our clients, focusing on results and seeing things through.
We are committed to honesty, trust, and transparency and we do the right thing even when no one is watching.
getting work done.
doing the right work.
getting work done.
We take our work seriously and strive to deliver exceptional results for every project so that you can get safe medical devices to your patients and users.
We take an outside perspective to overcome obstacles and find solutions together with our clients.
loving our work.
doing the right work.
getting work done.
We love what we do, and we do it with love.
We constantly learn, improve and develop, staying on the cutting edge to provide a service that’s anything but basic.