What is ISO 13485:2016?
While it shares a structure with ISO 9001, the standard has stricter requirements of its own: full product traceability, risk management across the device's entire life cycle, control of sterilization and clean environments, and a direct link to each market's regulatory requirements (COFEPRIS, FDA, the EU Medical Device Regulation, among others).
In many markets, certification is a mandatory prerequisite to commercialize medical devices, not just a competitive advantage.
Benefits of certification
- Access to markets and clients that require certification as a regulatory condition.
- Full product traceability for health authorities and customers.
- Formal risk management across the device's entire life cycle.
- Lower likelihood of product recalls and regulatory non-conformities.
- A solid foundation for regulatory registration processes across different countries.
Who it applies to
It applies to medical device manufacturers, critical component suppliers, distributors, and associated service providers (sterilization, calibration, maintenance) within the healthcare supply chain.
How we support you
Regulatory diagnosis
We identify the applicable requirements based on your product, risk class and target markets.
Implementation
We design the QMS, product risk management and the traceability controls required.
Certification
We support you through the certification audit and maintaining the system through regulatory audits.
Medical device specialization
We combine our ISO 9001 expertise with regulatory knowledge specific to the healthcare sector.
Ready to put this into practice?
Let's talk about your organization's specific challenges and how we can help you solve them.
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