No matter if we are talking about non-active or active medical devices, in vitro diagnostic medical devices (IVDs) or medical device software, we can support you along the way. The classification of your "borderline products" is also in good hands with our specialists.
fast and successful access to your key markets
As an independent globally operating consultancy, knoell's international team of more than 20 medical device experts includes specialists in biomedical engineering, software engineering, medical sciences and medical writing, pharmacology, toxicology, chemistry and biochemistry.
We support manufacturers of medical devices and in-vitro diagnostic medical devices (IVDs) with our extensive expertise at every point of the product life cycle. Our medical device experts support you in gaining access to global key markets like Europe, North & South America and Asia.
Together with our clients we build a sound market access strategy by identifying the most efficient route to place your products on the desired market.
Contact for Europe, Asia & the USA Contact for South America
Learn more about implementation strategies for IVDR with our e-Learning series!
In a series of 9 sessions we will help you to understand how the new IVDR will affect your product. Topics covered by our IVDR learning videos:
- Session 1: Implementation Strategies for IVDR – Timelines and Priorities
- Session 2: When Medical Devices and IVDs meet REACH
- Session 3: Classification under IVDR – Challenges and Opportunities
- Session 4: Roles and Responsibilities of Economic Operators under the IVDR
- Session 5: Performance evaluation and clinical evidence under the IVDR
- Session 6: Update of the technical documentation under the IVDR
- Session 7: Post market surveillance and vigilance under the IVDR
- Session 8: EUDAMED and UDI under IVDR
- Session 9: IVDR – Hands-on session with a virtual IVD example from IVDD to IVDR
No need to invest your valuable time to keep the project moving: our experienced project managers will assure that your project runs smoothly, no matter if we are talking about total outsourcing or just a smaller task within the submission process. This is how it could look like for you.
Authorities in most markets require medical device companies to maintain a quality management system to obtain device approvals and registrations. We implement and maintain quality management systems (QMS) that comply with QMS regulations in medical device markets.
- QMS - implementation / maintenance (e.g. ISO 13485, 21 CFR 820, RDC 16)
- MDSAP - implementation
- CAPA - support
- QMS - interim management
- Auditing - internal / supplier (on-site / remote)
Read more about our quality management and audit solutions for you.
From proof of concept to developing a sound design & product safety plan. We support you along the way. Non-active, active or software: find more details on our medical device design & development support here.
Knowing your regulatory environment is essential to stay in the market and to grow your business. With our global network of affiliates, knoell keeps track of the developments concerning global regulations for medical devices and IVDs.
Our team supports with
- Development of regulatory strategies
- Preparation of submission documentation
- Communication with notified bodies and competent authorities
Read more about our strategic and regulatory consulting solutions.
Benefit from our up-to-date expert training modules, seminars and workshops held on scheduled dates at our training premises, online or at a location of your choice and individually designed for you. Explore our knoell academy programme!