Can a medical device startup get ISO 13485 and EU MDR certified at the same time?

Yes. Elixion did it. EU MDR CE marking requires two things: Technical Documentation that proves your device is safe and conforms to MDR requirements, and a Quality Management System that covers the full device lifecycle. ISO 13485 is the standard used to certify that QMS. Because both share the same foundation, building them in parallel is more efficient than treating them as separate projects. Elixion completed both simultaneously on their first attempt, with CertHub handling the Technical Documentation structure and the QMS setup in one process.

How long does ISO 13485 certification take for a medical device startup?

For a startup building a QMS from scratch, 12 to 18 months is a realistic range. The main variable is how early documentation work starts relative to product development. Teams that build the QMS in parallel with the product move faster. Teams that document after the product is built spend months reconstructing decisions from memory and scattered files. A modern QMS platform helps, but only if it is set up with the right structure from the start.

Do I need a regulatory consultant, a QMS platform, or both?

Both. A QMS platform stores and structures your documentation. A regulatory consultant tells you what belongs in it and how the standard applies to your product type. One without the other leaves a real gap. Most startups that try to self-certify discover this after their first notified body feedback. Correcting scope and documentation errors at that stage takes months. Elixion started with CertHub's regulatory consulting from day one, then used the platform alongside it. Mario describes the combination as the approach that makes certification work.

What does EU MDR require for a medical device that combines hardware, software, and a sterile component?

EU MDR requires a Technical File that covers the complete device system. For a combination product, that means hardware design documentation, software lifecycle records (IEC 62304), sterilization validation, and risk management across all components (ISO 14971). Each element generates its own documentation, and all of it comes together in one Technical File. The Declaration of Conformity is then the manufacturer's formal statement that the device meets MDR requirements, based on that Technical File.

How do you pass ISO 13485 certification on the first attempt?

The QMS has to reflect how the team actually works. Auditors read procedures and then look for records proving those procedures were followed. A QMS written to pass an audit rather than to run a business is obvious in review. The other common failure point is scope. Teams that underscope their Technical File find gaps during the audit that take months to correct. Correct scope, documented processes, and records built from day one are the consistent factors in first-attempt certification.

ISO 13485 and EU MDR: Elixion's First Submission

ISO 13485 and EU MDR certification: questions medical device startups ask

What founders and regulatory managers ask before starting the QMS and certification process.