Our Services
QUALITY SYSTEM CREATION, REMEDIATION, Gap analysis and Auditing
QUALITY SYSTEM CREATION, REMEDIATION, Gap analysis and Auditing
QUALITY SYSTEM CREATION, REMEDIATION, Gap analysis and Auditing
- ISO 13485:2016.
- ISO ISO 14971
- ISO 9001:2015.
- 21 CFR 820 GMP / QSR.
- TGA - Australia.
- ANVISA - Brazil.
- CMDR - Canada.
- MO#169 - Japan.
- MDD 93/45/EEC.
- EU MDR 2017/745.
- CAPA experts.
- Root cause resolution focused.
- Design control experts.
- Team approach oriented.
ATTAIN & RETAIN Quality System CERTIFICATIONS
QUALITY SYSTEM CREATION, REMEDIATION, Gap analysis and Auditing
QUALITY SYSTEM CREATION, REMEDIATION, Gap analysis and Auditing
Trained and experienced auditors in:
- MDSAP
- ISO 13485:2016
- 21 CFR 820
- ISO 9001:2015
- MDR 2017/745
SPEED TO MARKET
QUALITY SYSTEM CREATION, REMEDIATION, Gap analysis and Auditing
SPEED TO MARKET
- We customize quality systems to your needs.
- Right-size the QMS for your business.
- Start to finish within 90 days.
- Certifications often received within 6-9 months.
About Us
Why Choose QMS Specialists?
Our focus is on start-up through medium-size companies, which are resource-needy, for Regulatory and Quality expertise - NOW!
We know that when you have a Regulatory need, you need it NOW.
Let us be your domestic and international Regulatory experts. We can help you with your medical device Quality System AND product development needs.