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Quality Systems

We know all facets of medical device quality systems.

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21 CFR 820 (QSR).  21 CFR 4.  ISO13485.  ISO14971.

EU MDR STeD Files.  IEC 62304.  ISO 62366.  

RoHS.  WEEE.  GHTF/IMDRF.  REACH.*

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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. 

 

Have a 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

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