Non Conformances FAQ
What is a Non Conformance?
What is CAPA?
How should non-conformity procedures and processes be set up?
We have all the answers and more…
EU IVDR
Implant Cards FAQ
What is the purpose of an implant card?
When are they applicable?
What are the guidelines?
We have all the answers and more…
Gap Assessment FAQ
What is a Gap Assessment?
How can it help?
What does it involve?
Read on to learn more…
Common Standards FAQ
Why are ISO standards important for manufacturers?
What are Harmonised Standards?
How do you determine which are applicable?
We have all the answers and more…
EU MDR Article 59 and CE Marking for Medical Devices
Article 59 sets out how authorisation of CE Marking requirements derogation for medical devices (not IVDs) can be done. Clin-r+ provides guidance on Article 59 and CE mark derogation.
EU MDR Article 59 and CE Marking for Medical Devices Read More »
Common Standards
ISO standards help medical device manufacturers and the medical industry comply with the evolving ‘State of the Art’, international best practices, streamline processes, and improve patient safety and satisfaction. These standards improve risk management and help businesses fulfil legal and industry standards. There are numerous ISO standards in place, and Clin-r+ has constructed this paper to give you an overview of the most common standards for the MedTech industry.
Clinical Investigations for Medical Devices and IVD
Clin-r+ outlines the requirements and considerations manufacturers should review to ensure that Clinical Investigations they undertake are well researched to ensure a return on investment.
Clinical Investigations for Medical Devices and IVD Read More »
Intended Purpose, Intended Use, and Indications for Use
Intended Purpose, Intended Use and Indications for Use are all terms that are often confused. Not only do they sound similar, but their definitions in relation to a device can be easy to mix up. Clin-r+ explains what they actually mean.
Intended Purpose, Intended Use, and Indications for Use Read More »
Medical Device IFU & eIFU
A Medical Device IFU is an essential part of your Technical Documentation. Clin-r+ provides insight and focuses on formulating an IFU to comply with EU MDR in this paper.
Labels for Medical Devices
Labels for medical devices are indispensable. Clin-r+ are here to help you understand labels, the MDR requirements, and how to put them into action on your systems.
