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ISO ComplianceAchieve ISO Compliance

ISO compliance resulting in certification is not required for biotechnology companies in the United States. Experience with ISO 13485 and ISO 14971 Certification is necessary for global distribution of your product, and ISO 9001 Certification demonstrates your commitment to service. Documented compliance to an ISO Standard, even in the absence of certification, speaks volumes about the kind of partner you will be.

Benefits of ISO compliance for biotech companies:

  • Accountability for your operations
  • A solid foundation for business growth
  • A focus on defect prevention, not detection
  • Industry recognition, especially for potential customers
  • Ease of entry into new markets

We help biotech companies through each phase of certification, from process and documentation development through audit review. Once certification is achieved, we help our clients:

  • Streamline processes to be more effective, not just compliant
  • Implement corrective action for prevention of problem recurrence
  • Audit customer requirements

MethodSense provides certification and compliance services that include:

For more information about how we can help with ISO certification and Quality System (QS) consulting, contact us.