Consulting for Medical Device Manufacturers ISO 13485 / 21 CFR 820
Consulting for Medical Device Manufacturers ISO 13485 / 21 CFR 820

Our experienced consultants support medical device companies in preparing for certification for ISO 13485, 21 CFR 820 during the following stages and elements. Both quality systems have parallels with ISO 9001 however, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer feedback.

Quality is a cornerstone of any regulated industry and requires a high level of understanding of the subject in order to deliver solutions that are suitable for the size of the company, its products and its people. At ITC Validation Consultants we pride ourselves on being able to provide support throughout the full spectrum of quality activities which are relevant to any industry.

We believe that people make all the difference.

Quality System Development

  • Gap Assessment
  • System Development
  • Internal Audit
  • Mock Audit
  • Supplier Audit

Computer System Validation (CSV)

  • Design Lifecycle
  • Software and Hardware Development
  • Project Planning
  • Requirements Definition
  • Specification Development
  • Risk Management
  • Traceability
  • Design Review

Product and Process Development

  • Prototyping
  • Manufacturing
  • Logistics
  • Verification
  • Validation
  • Submissions Support