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 ISO 13485:2003 Medical Device Standard
As the medical device derivative of the ISO 9001:2000 standard, the ISO 13485 standard synchronizes medical device regulatory requirements and integrates requirements for:
- Manufacturing
- Installation,
- Servicing
- Record-control
- Sterilization
- Risk management
Organizations can register to ISO 13485 as a standalone or in conjunction with an ISO 9001 registration. ISOmatrix technical experts use decades of practical ISO 13485 implementation experience to help our client companies prepare, execute, and succeed. Reaching further, ISOmatrix also supports post-certification activities to keep your system optimized and continually improving.
BioPharma - Regulatory, QC, cGMP, and Validation
Our partner, PQC Consulting, Inc., provides a wide range of expert consultation and training services in the areas of CGMP, Regulatory Affairs, Quality Control, Quality Assurance, and Validation to the pharmaceutical and biopharmaceutical industries.
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