We help MedTech companies elevate their medical device offering.

With EU Medical Device Regulation (MDR) becoming effective in May 2021, any interventional health software that is placed on the EU market will need to be classified as a medical device. Developing companion apps for medical devices can be challenging to do alone.

It requires:
  • Software development that adheres with medical device regulatory standards ISO 13485 and IEC 62306. This allows medical device companion apps to be classified as a medical device with notified regulatory bodies.
  • An interdisciplinary team of project managers, software engineers, UX designers, medical, security and regulatory domain expertise.
  • Patient and clinician-centric design expertise.
  • In-depth experience in determining and executing the optimal solution rollout strategy.

We work with industry-leading MedTech companies to design and develop patient-centric companion apps for medical devices that provide a more holistic offering of care.

Security and medical-grade regulation are ingrained in our DNA. Zendra is certified to medical device regulatory standard ISO 13485:2016 and compliant with software development standards for medical-grade software IEC 62304 and 21 CFR Part 11.

No matter where you are on your MedTech journey, we are here to help.

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