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Design to Regulatory Standards

We have the expertise and processes required to design, develop and manufacture products for regulated markets.

Satisfying international standards for areas such as safety, risk management, electromagnetic compatibility and materials compatibility is a prerequisite for successfully placing medical devices, biomedical instruments and advanced therapeutic products on the market. From concept to pre-production, we track a product’s alignment with regulatory standards by performing compliance testing and working with regulatory agencies. By designing to the requirements of these regulatory standards early in the development process, we are able to manage risk, cost, and time to market for our clients.

We have helped our clients obtain regulatory approvals including 510(k), PMA, CLIA Waiver and CE marking by incorporating the requirements of the following standards and regulations, amongst many others, into our processes and quality systems:

  • ISO 9001 (Quality management systems)
  • ISO 13485 (Medical devices – Quality management systems)
  • ISO 14971 (Risk management of medical devices)
  • IEC 62304 (Medical device software – Software life cycle processes)
  • EN 61010 and EN 60601 (Safety for medical electrical equipment)
  • GMP and GAMP (Good Manufacturing Practice and Good Automated Manufacturing Practice)

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