Nectar Product Development

Nectar is ISO 13485:2016 certified – but what exactly does that mean?

Medical devices will invariably be used by various members of the healthcare team and vulnerable patients. In some cases, these devices could literally be the difference between life and death. At Nectar, we have always adopted a user-centered approach, with multiple detailed safety assessments at every step of the process. We believe in the importance of adhering to regulatory systems that are in place to ensure the quality and safety of medical devices is checked throughout the design and development process. This will help maintain consistency in a saturated market and ensure all end-users are kept safe.

The International Organization for Standardization (ISO) is an example of one of the organizations that plays a key role in these safety checks – they have established global standards for quality and risk management of materials and processes. They have certifications across different industries, including medical devices. Each certification is given a different numerical classification – here at Nectar, the ISO certification we currently hold is ISO 13485:2016.

An ISO 13485:2016 certified Quality Management System (QMS) is proven to support this undertaking, allowing companies like Nectar to organize and track every single variable in the creation of such sophisticated and novel devices.  Whilst it is true that many product development companies operate to ISO 13485:2016 standards, obtaining official accreditation requires rigorous internal audits; their completion demonstrates to regulators that a company has wholly dedicated their operation to the process of ensuring that their products are safe, reliable, and meet the highest quality standards.

The benefits of an ISO 13485:2016 certified QMS extend beyond guaranteed patient safety. It provides you with an extra layer of credibility that will aid you in the development process. Banks and investors will often have checks in place to see if companies are ISO 13485:2016 certified as a marker of reliability. The certification assures those who are providing capital funding that the firm designing the proposed product is reputable and safe – two important markers for success and profitability.

At Nectar, we are proud to have held our ISO certification for over 3 years now – our product development process is tried and tested, with rigorous high-quality design, and manufacturing standards for our clients. As a client and a consumer, you can rest assured that Nectar is achieving the most prestigious standards possible in the global market.  If you would like to learn more about how Nectar’s ISO 13485:2016 certified QMS can help you and your product development process, please contact us.

Nectar is an award-winning design & engineering consultancy with a specialization in medical device development. We are proudly 13485 certified, we adhere to the highest industry standards. Nectar has been an industry leader in Southern California for over 25 years. Our proven user-centered design process has facilitated the successful launch of hundreds of products in the market.

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    We are an ISO 13485-certified design and engineering firm based in Southern California, specializing in the development of cutting-edge medical devices.

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