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REGULATORY COMPLIANCE

A clear path to compliance

Genesys Medical Devices undertakes all the all the required activities to gain regulatory approvals in target markets (TGA, FDA, CE etc)  including:

  • Compliance Planning for medical standards, including

    • IEC 60601-1 (safety)

    • IEC 62304 (medical software)

    • IEC 62366 (usability)

    • Lab testing and certification against these standards

  • ISO 13485 quality management compliance including:

    • Design controls

    • Design and development planning and reporting

    • Risk assessment and management (ISO 14971)

    • Verification and validation processes

    • Audit of subcontractor quality systems

  • Medical Device File preparation including

    •  Device Technical File

    • Certification planning (against TGA, FDA, CE, etc)

 

Why TechReg is Needed

TechReg is the term we use to describe the role of engineering specialists in helping you comply with regulatory regimes. TechReg goes well beyond developing a device or system that adheres to the relevant standards.

 

There are many regulatory consultants who can tell you WHAT you need to comply with. Very few can tell you HOW to develop a product which complies, generally because they are not expert in the engineering involved. 

Companies developing regulated products or devices must set up quality management and compliance systems for two core reasons:

 

  • Demonstrating product compliance with technical standards

  • Gaining certification with regulatory authorities

 

Medical Device Compliance 

Genesys establishes all the necessary systems and documentation to comply with the key MedTech standards including:

  • ISO 13485 - Medical devices -- Quality management systems

  • ISO 14971 -Medical devices -- Application of risk management

  • IEC 60601-1 - Medical electrical equipment performance and safety

  • IEC 60601-1-2 - Electromagnetic Compatibility

  • IEC 62034 - Medical Device Software Life Cycle


Active medical devices are also items of electrical equipment. Genesys also ensure all the relevant standards for electrical devices are adhered to including:

  • AS 3100 - General requirements for electrical equipment

  • IEC 60950 - Information technology equipment safety

  • Electromagnetic compatability (emissions and immunity)

  • Radiocommunications

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