launch medical devices with regulatory confidence.
Practical QA/RA guidance for MedTech companies navigating FDA, MDR, and ISO 13485 without unnecessary stress or guesswork.
20+ years in medical device QA/RA
global compliance expertise: FDA, EU MDR, ISO 13485, MDSAP and more
global compliance expertise: FDA, EU MDR, ISO 13485, MDSAP and more
global compliance expertise: FDA, EU MDR, ISO 13485, MDSAP and more
global compliance expertise: FDA, EU MDR, ISO 13485, MDSAP and more
global compliance expertise: FDA, EU MDR, ISO 13485, MDSAP and more
proven track record with clients across the MedTech spectrum
global compliance expertise: FDA, EU MDR, ISO 13485, MDSAP and more
proven track record with clients across the MedTech spectrum
Sharon is one of the best all-around QA/RA Consultants that I have worked with. She understands the industry, the regulations, and the balance between business needs and compliance. (A.L)
qualityworks. experience
qualityworks. helps medical device companies get their solutions on the market; with over 20 years of proven experience in the medical device industry, we offer our knowledge, competence and experience with a variety of quality assurance and regulatory affairs consulting services customized to fit your specific needs.
why qualityworks.
qualityworks. provides quality and regulatory services for small to medium medical device companies.
We help medical device companies with:
- Regulatory strategy and submissions (FDA, MDR, etc.)
- QMS setup and scale (ISO 13485/MDSAP, EU MDR, QMSR compliant)
- Audit preparation and gap assessments (ISO 13485, MDSAP, EU MDR, FDA)
- Internal audits
- Supplier audits
- CAPA handling
- Risk management
- Technical file creation / review
why clients choose qualityworks.
- 20+ years hands-on experience
- Proven success with ISO 13485, FDA, EU, MDSAP
- Fluent in both strategy and execution
- Personalized support – you're never just a client
you’ve seen what we do - now let’s explore how we can help your device succeed.
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ready to move forward with confidence?