ISO 13485:2016

What Is ISO 13485:2016 ?

(BS) (EN) ISO 13485:2016 defines standards for a quality management system that must demonstrate an organization’s capacity to consistently supply medical devices and related services that fulfil customer and regulatory requirements.

Unless otherwise specified, the requirements of ISO 13485:2016 apply to all companies, regardless of their size or nature. Where criteria are stated to relate to medical equipment, the rules also apply to the organization’s connected services.

ISO 13485:2016 Can Help You Comply With EU IVDR & MDR

EN ISO 13485 is a parallel standard issued to create a QMS in the medical device industry in the European Union. The requirements of these two standards are identical, and the entirety of the ISO 13485:2016. However, EN ISO 13485 includes several invaluable tables that align the ISO 13485:2016 requirements to MDR 2017/745 and IVDR 2017/746. It is expected that a new version of EN ISO 13485 will be released soon.

ISO 13485 Certification Process

Anyone who has applied for medical device product certification does not need to have ISO 13485 certification. Implementation of ISO 13485 is required for CE Marking under MDR or IVDR.

ISO 13485 Consultants

ISO 13485 Regulatory Consultants assist clients in meeting their evolving business and regulatory requirements ( Country Specific) Knowledge and expertise from the consulting team are frequently necessary to align with a certain sector of choice and finally achieve error-free compliance.

Integrating EN / BS ISO 13485 With 21 CFR 820

We advise the US Food and Drug Administration on regulatory matters. With our assistance, manufacturers may combine both standards into a single documentation system. Our ISO 13485 Consultants have experience with FDA auditors and have worked on comparable projects.

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