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  • Tim Kannegieter

Genesys Successfully Completes ISO 13485 Recertification Audit

Updated: Aug 28, 2023

Genesys Electronics Design, a leading provider of electronic solutions for high reliability devices, is proud to announce the successful completion of its ISO 13485 recertification audit. The company has once again met the rigorous standards set by the International Organization for Standardization (ISO) and demonstrated its commitment to delivering high-quality products and services.

ISO 13485 is an internationally recognized standard for quality management systems specifically tailored to the design and development of medical devices and can be used for other high reliability products such as those used in mining, aerospace and similar regulated industries.

Compliance with this standard ensures that design consultancies such as ours meet stringent requirements for the design, development and maintenance of complex devices. Certification and recertification is a significant achievement for any organization, as it involves a comprehensive evaluation of the company's processes, procedures, and quality management system (QMS) by independent auditors, in this case BSI.

"While many see quality as a check box exercise, we implement our QMS that adds value for us and our customers," said Geoff Sizer, CEO of Genesys Electronics Design. "It ensures that we are embedding best engineering practices into our routine activities and continually looking for ways to improve them."

By choosing to work with and ISO 13485 certified consultant such as Genesys, customers benefit in multiple ways including:

  1. Compliance with regulatory requirements: Medical device manufacturers must comply with regulatory requirements and related standards. By partnering with Genesys customers are assured that their electronic assemblies, software and systems are designed and developed in accordance with the requirements of ISO 13485, reducing the risk of non-compliance. It also eases the burden of Manufacturers having to audit Genesys’ QMS during supplier approval, as our ISO 13485 certificate allows them to deem our QMS as satisfying ISO 13485 QMS requirements.

  2. Improved risk management: ISO 13485 emphasises risk management throughout the product development lifecycle. Genesys Electronics Design's adherence to this standard ensures robust risk assessment and mitigation processes, resulting in safer and more reliable devices. This is best practice for any industry where safety and reliability are of paramount importance.

  3. Enhanced product quality: The emphasis on stringent quality control measures, including thorough verification and validation procedures means that the resulting products are of the highest possible quality standards minimising the potential for product failures or malfunctions. Genesys’ robust ISO-13485 compliant design, development, verification and documentation procedures allows manufacturers to deem our design outputs as being compliant with ISO 13485 and applicable regulatory standards requirements.

  4. Streamlined design and development processes: The ISO 13485 framework ensures efficient and effective design and development processes are followed, with an emphasis on good project management, providing a guarantee of good value and increasing the likelihood of products being delivered on time and within budget.

Looking ahead, Genesys is expanding its ISO 13485 certification to include mechanical engineering and usability engineering. This expansion highlights the company's dedication to providing comprehensive solutions and further solidifies its position as a trusted partner in the high-reliability device industry.

The newly issued ISO 13485 certificate, was issued effective today and is valid through to 22 June 2026. View the certificate and our Quality Guarantee.

For more information about our design services in the Medical Devices industry visit our Medical Devices web page.

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