COMPLIANCE SERVICES

Compliance Made Easy

for Electronic Devices

Genesys helps you with the establishment and integration of the core technology and organisational systems needed for regulatory compliance.

 

We also assist you in all technical analysis required and planning for projects to meet all regulatory requirements, shown below:

 

Why TechReg is Needed

TechReg is the term we use to describe the role of engineering specialists in helping you comply with regulatory regimes. As shown in the diagram above, TechReg goes well beyond develping 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 supports compliance in all industries. For example the Medical Device industry has a large number of specific requirements which we are expert in.  Key MedTech standards are:

  • 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


Many of the industrial standards in the next panel also apply to medical devices.

For more information view our page on Medical Device Development or download our whitepaper on What you Need to Know Before Developing Electronic Medical Devices

View the full list of electronic device standards we have experience addressing.

 

Industrial Device Compliance

Genesys can provide support for any standard which applies to devices we develop. We routinely work in areas related to quality, risk management, software development and electrical safety. Key headline standards we have expertise in are:

 

  • AS 3100 - General requirements for electrical equipment

  • IEC 60950 - Information technology equipment safety

  • Electromagnetic compatability (emissions and immunity)

  • Radiocommunications

For more information view our page on Industrial Device Development or download our whitepaper on What you Need to Know Before Developing Smart Electronic Devices

View the full list of electronic device standards we have experience addressing.

 
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