Medical Device Quality and Regulatory Compliance

FDA (cGMP/ QSR), ISO, MDD and Remediation

medical_device_quality

Ever wonder why companies face recurring problems (CAPA or customer complaints), and why production and process controls, management responsibility, controls, etc., continue to show up on Warning Letters?

Creating a quality system that adds value beyond compliance makes lasting solutions easy to implement.  Working with people who actually perform the work, writing procedures is the key to success.  Also, we've found that precise root cause analysis makes CAPA solutions become permanent.

We assist clients with compliance including CAPA, handling customer complaints, production and process controls, management controls, validations and solutions to most regulatory compliance problems:

  • FDA cGMP and QSR  Compliance
  • Quality manual, policy and procedures
  • 483 and Warning Letter Responses
  • Combination products
  • Management Controls
  • Audits (Internal & External)
  • Design Controls
  • Production & Process Controls
  • Corrective and preventive actions (CAPA)
  • Validation - Process, Package, Sterilization
  • Failure Investigation
  • Identifying true Root Cause
  • Quality Engineering
  • Training
  • Effective Design Control
  • Risk analysis (design, process user risks)
  • Risk Management & Mitigation
  • Complaints handling
  • MDR
  • Single Use & Reuse

ISO and EU:

  • QSR and ISO Integration
  • ISO 13485 Quality Systems
  • ISO 14971 Risk Management
  • ISO 62366 – medical device usability
  • ISO 11607 Medical Sterile Packaging
  • ISO 11135 Ethylene Oxide Sterilization
  • ISO 11137 Irradiation (Gamma, e-Beam)
  • ISO 10993 Biocompatibility
  • MDD and AIMD Compliance
  • Technical File Development

Audit and Supply-chain:

Conducting audit for audits sake is simply not enough.  Creating working relationships with vendors, providing assistance and developing meaningful communication is the key in supply-chain management.

  • Purchasing Controls
  • Auditor Training
  • Supplier/Vendor Audit
  • Internal Audit