What is ISO 13485:2016 ?
(BS) (EN) ISO 13485:2016 specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Requirements of ISO 13485:2016 apply to organizations regardless of their size and type, except where explicitly stated. Wherever requirements are specified as applying to medical devices, the conditions apply equally to associated services supplied by the organization.
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
ISO 13485 Certification is NOT mandatory for anyone who even applied for medical device product Certification. ISO 13485 Implementation is compulsory for CE Marking under MDR or IVDR. The following are the critical steps in ISO 13485 certification.
- Identification of activities and medical devices to be covered in the certification scope
- Identify the process owners
- Identify the scope exclusions
- Draft Quality Manual and define Quality Policy
- Identify the mandatory procedures and draft the policies with the help of process owners.
- Implement the procedures and create documentary evidence for each activity carried out
- Conduct Internal Audit and close all GAPS
- Apply with Certification Body (CB) and invite for an onsite audit
- Answer all queries / NC from CB
ISO 13485 Consultants
ISO 13485 Regulatory consultants work to provide solutions to the client’s changing business and regulatory needs ( Country Specific). The consulting team’s knowledge and experience are often required to become aligned with a specific industry of their choice and eventually become error-free compliance.
Our Fees
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OFFSITE ACTIVITIES |
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Drafting of Quality Manual, Mandatory Procedure and Important templets |
1400 USD |
20 Working Days |
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Process owner Interaction and Guidance via Skype / Zoom / or any other medium |
349 USD per hour |
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ONSITE ACTIVITIES |
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Process owner Interaction and Guidance |
849 GBP per Man-day |
Average 2 hours per mandatory procedures |
| Internal Audit | 849 GBP per Man-day |
Two man-days are sufficient for small and medium-sized companies |
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IQA Training / ISO Awareness training |
949 GBP per Man-day |
1 to 2 man-days |
Integrating EN / BS ISO 13485 with 21 CFR 820
We work as regulatory advisors for the US Food and Drug Administration. Manufacturers may integrate both standards into a single documentation system with our help. Our ISO 13485 Consultants have worked on similar projects before and have dealt with FDA auditors.
Contact Us
Need more information? You can always send us an e-mail or fill the contact us form. We will take care of your request as quickly as possible.
