THE BRIEF

ROLE: Validation Lead to validate a clean room Class D
Business area: Supplier to medical device companies

WHAT WE DID

We led the work to improve and validate an existing clean room to meet requirements in ISO8 (ISO 14644) and Class D (EU GMP).  The assignment aslo included creation of supporting processes (eg Change Control)    

ABOUT US
Visinge Consulting supports customers in regulated business with professional services.
CONTACT
FIND US
  • Gribbyvägen 1C, 187 68 Täby SWEDEN