Are you looking for a QA & RA partner in Medical Devices? Then you are at the right place.
We deliver solutions customized to your business needs.
Making complex legislation pragmatic and user-friendly is our passion.
Welcome to QA MED Solutions
WHAT WE OFFER:
🏆 Quality Assurance:
ISO 13485 QMS for medical devices – or your own standard
QMS implementation, Due diligence audit, Internal audit
⚙️ Regulatory and Quality training and education – customized for your needs:
EU MDR Compliance, EN ISO 13485:2016 QMS, Technical Documentation, Post Market Surveillance, Risk management, Quality Strategy Advice
🎯 MDR readiness and implementation:
Gap analysis, Clinical /regulatory strategy, preparation of Clinical evaluation and Technical documentation (primarily class I devices)
🌸 Regulatory consulting:
Gap analysis, EUDAMED registration, Risk management ISO 14971, PRRC (Person Responsible for Regulatory Compliance), Regulatory affairs training, Regulatory Strategy Advice, CE-marking, labelling and IFU advice, Recall procedures
Company Details
- Employees
- 7
- Founded
- -
- Address
- Strandvejen 14, 1, Middelfart,south Denmark 5500,denmark
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- glove-insite.com
- Keywords
- CE labelling of Class I Medical Devices, Medical Device Regulation, Quality Management systems, ISO 13485.
- HQ
- Middelfart, South Denmark
Qa Med Solutions Questions
Qa Med Solutions's website is glove-insite.com
Qa Med Solutions's LinkedIn profile is https://dk.linkedin.com/company/qa-med-solutions
Qa Med Solutions has
7 employees.
View email and phone details for 7
employees at Qa Med Solutions.
Qa Med Solutions's industry is
Business Consulting and Services
Qa Med Solutions's top competitors are
Coachment,
Lægemiddelstyrelsen (Danish Medicines Agency),
Bis Media,
Medipart Aps,
Boomarine,
Tecnologias Sanitarias,
Lederkonferansen Bygg Ren Verdi,
Carl Hansen & Søn,
Novartis,
Abena.
Qa Med Solutions's categories are Business Consulting and Services
Qa Med Solutions's founding year is 2016
