We know all facets of medical device quality systems.
21 CFR 820 (QSR). 21 CFR 4. ISO13485. ISO14971.
MDD Tech Files. EU MDR STeD Files. IEC 62304. ISO 62366.
RoHS. WEEE. GHTF/IMDRF. REACH.*
Whether you need an external audit to insure compliance or
already have findings that need to be addressed and resolved,
we will be with you the entire way.
New product or process that requires validation? No problem.
Corrective and Preventive Action (CAPA)
Root Cause Analysis
Production and Process Controls
Document Change Control Systems
Labeling, including Unique Device Identification (UDI) requirements
Purchasing / Supplier / Material Controls
* QSR - Quality Systems Regulation - FDA Medical Device Requirements : 21 CFR 4 for Combination Products : MDD - Medical Devices Directive (EU) : EU MDR - Medical Device Regulations :
RoHS - Restriction of Hazardous Substances : WEEE - Waste Electrical and Electronic Equipment Directive : GHTF - Global Harmonization Task Force : IMDRF - International Medical Device Regulators Forum :
REACH - Registration, Evaluation, Authorization, Restriction of Chemicals