Chart your course through compliance

How can we help you?

The services of QAIR.io can broadly be divided into six different categories. Contact us to find out if we can support you if your question is not listed.

Quality Management

  • Implementation of Quality Management Systems per ISO 13485
  • Auditing your Quality Management System (internal audit)

Regulatory Affairs

  • Preparing submission documentation for regulatory authorities
  • Supporting with the implementation of Electronic Requirement Management Systems such as Matrix Requirements
  • Practical Regulatory experience in Artificial Intelligence enabled Medical Devices

Information Security

  • Implementation of Information Security Management Systems per ISO 27001 / ISO 27017 / ISO 27018 / NEN 7510
  • Implementation of UK Data Protection and Security Toolkit (DSP)

Interim Roles

  • Person Responsible for Regulatory Compliance (PPRC)
  • Data Protection Officer (DPO)

Authorized Representatives

  • Register your devices in EUDAMED
  • Represented on your device labeling
  • Perform regulatory review on technical documentation

Compliance Monitoring

  • Regular audits and gap analyses.
  • Monitoring regulatory changes regarding AI and Medical Device Legislation.
  • Responding to regulatory inquiries and investigations.

The strengths of QAIR.io

Knowledged and experienced in working with AI-enabled SaMD
Highly flexible in how we work with you
Tailor-made Quality Procedures that meet your needs
Proven success in start-up and scale-up companies
Someone doing high quality work
Someone thinking hard about regulations

Our story

QAIR is a highly flexible and motivated team ready to support you. Even though our backgrounds are different, we share a common story.

With a view of contributing to innovation in the medical devices field, we both joined early stage start-ups. We first-hand experienced the challenges and struggles in early-stage regulatory decision making, certification strategies, the pains that come with scaling up and the process of being acquired by larger players in the medtech industry.

We decided that with this shared experience we are in a suitable position to support starting, early-stage manufacturers in the development of their medical devices.

Leon Doorn, M.Sc.

Master in Health Sciences, and a Bachelor in Nursing

More than 15 years of practical working experience in the global medical device industry with various positions in Quality, Regulatory and Information Security.

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Ivo Flipse, M.Sc.

Master in Human Movement Science, and a Bachelor in Human Kinetic Technology

With over 15 years of experience in the medical device industry, spanning roles in project management, software development, and product development, he has established a career characterized by innovation and expertise. Notably, as a Project Manager at Zimmer Biomet, he led the development of the ONE Planner Hip, a web-based preoperative solution that received 510(k) clearance and MDR certification, showcasing a deep understanding of regulatory compliance and quality management.

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