Qualification and Regulatory design for successful qualification and certifications

We have experience designing electronics products for a range of industries, from medical, automotive, consumer to industrial.

We realize the compliance requirements for various applications and are cognizant of the regulatory requirements applicable to the product and follow steps towards requisite compliance from the get go.

This helps us implement and evolve documentation accompanying design for various approvals, from PMA FDA submission to ISO26262 compliance.

QUALIFICATIONS AND REGULATORY

We consider the target application of your device and with our expertise, provide a list of certifications applicable. Once the certifications are outlined, it helps us form the necessary framework for documentation and compliance. This minimizes the delays and extra costs. There are various certifications for electronic products such as FCC requirements for electronic products in North America, ISED for Canada, CE standards in Europe, RoHS for global market, UL safety standard for North America and various others.

Preparing for Certification: Product Design

Product safety and regulatory compliance defines and shapes the product design, We consider the implications from the bread-boarding stage and evolve the product design and documentation to not only cater to the requirement but also to optimize on the post-design manufacturing maintainability. We have experience supporting various certifications such as:

COMMON CERTIFICATION REQUIREMENTS

  • ISED, FCC, EMC Directive
  • RoHS directive, WEEE regulation, Low Voltage directive, EMC Directive, etc.
  • CSA, UL, NRTL, IECEx, etc.

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