Next generation Medtech and IVD

We help you navigate both the local and global regulatory landscape for your product within medtech or In vitro diagnostics (IVD). Whatever the area & scope, we are here to help you ensure the right quality for your business. Both today and tomorrow.

Large, small or in between

Say that you need help all the way from product development to market entry. Whatever your needs, we're here to help. Whatever your product classification, company size or scope of assignment, we can support you by matching the right skills to your specific needs. From product development, process work, quality systems, GAP analyses, and technical documentation to market access, clinical evaluation, support and advice on specific issues, software as a Medical Device, and contact with authorities or Notified Bodies - we can help you. Our team has a deep understanding and up-to-date knowledge of the requirements and regulatory processes involved. If you are looking to update your organisations skills, our Academy has several training courses in this area. Take a look and see what's right for you.

Medtech & IVD services

Healthcare compliance
We help healthcare providers and diagnostic laboratories with regulatory advice, quality management, in-house manufacturing and customisation according to MDR and IVDR, inspections of medical devices and GAP analyses according to MDR, IVDR and ISO17025. In practice, this means that we make sure you have what you need to meet all current requirements.
Quality assurance
Whether you need help to develop or improve your Quality Management System (QMS), someone to implement your electronic Quality Management System (eQMS) or to produce GAP analyses according to MDR, IVDR, ISO13485, FDA CFR 820 and ISO17025, we have the right expertise. Or why not bring in an experienced consultant to lead equipment qualification, process validation or software verification?
Regulatory support
Our experienced consultants - ranging from QA engineers to quality assurance managers - can help you produce your entire technical documentation or just selected parts (such as clinical evaluations, risk analysis or biocompatibility). We can also assist with market access applications in other countries, communicate with authorities as well as notified bodies and perform GAP analyses according to MDR, IVDR, ISO13485, ISO14971, ISO 15189, FDA CFR 820 and ISO60601, among others.
Audits
Thanks to our many years of internal audits and supplier evaluations, we can help you prepare for audits by a notified body. You can also have an internal auditor work alongside us for learning purposes.
Clinical studies
We can help you with project management, study coordination, application for authorisation, statistical analysis and regulatory advice on clinical studies involving medical devices or pharmaceuticals.
Compliance partner
A Compliance Partner is just what it sounds like - customised expert reinforcement that helps you with exactly what you need, when you need it. With no full-time contracts or commitment periods, our specialists support you as advisors, experts or operational support whenever you need an extra hand or brain.

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Questions about Medtech & IVD?

Contact an expert

Cecilia Fällman

Chief Sales Officer
Cecilia Fällman
Chief Sales Officer

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