Quality Systems

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.

 

  • Design Control

  • Risk Management

  • Design Transfer

  • Corrective and Preventive Action (CAPA)

  • Root Cause Analysis

  • Production and Process Controls

  • Document Change Control Systems

  • Software Controls

  • Labeling, including Unique Device Identification (UDI) requirements

  • Purchasing / Supplier / Material Controls

  • Audits

* 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