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…
Technical Documentation
Medical Device Non Conformances
Non-conformances (NCs) and non-conformance reports (NCRs) are important for medical device manufacturers to understand and manage correctly. CLIN-r+ highlights the key information that manufacturers need to know.
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.
Orphan Medical Devices
The EU MDR’s regulations on clinical data ensures that the medical device being used on the general public for their treatment or diagnosis is safe. However, there is a category of devices, known as ‘orphan medical devices’, that may suffer if special consideration isn’t provided to it. CLIN-r+ looks at what they are and what this means.
Gap Assessment
An MDR gap assessment is the process of looking at a medical device’s technical file in a systematic way to determine if it meets all of the relevant MDR requirements. It is the first and most important step in understanding what needs to be done for a device to become MDR compliant. CLIN-r+ shows how a gap assessment can quickly identify important information.
EU MDR Requirements for Implant Cards
EU MDR requires manufacturers to provide “implant cards” for patients with implanted medical devices. The intention is to make crucial information about implants easily accessible to patients. CLIN-r+ explains what manufacturers are responsible for.
Quality Management System (QMS)
A Medical Device Quality Management System (QMS) is a set of policies, processes, and procedures that a medical device manufacturer uses to ensure that their products are safe and effective for their intended use. CLIN-r+ explains what it is, and why it’s so important for manufacturers.
Technical Documentation FAQ
Are there any guidelines for the structure of the Technical Documentation?
What should be in each section? What do Notified Bodies expect to see?
We have all the answers…
You Got CE Marked – What’s Next for your Medical Device?
The CE mark is a major milestone for most medical devices. It can take a long time to obtain and be a challenging process. CLIN-r+ looks at the manufacturer responsibilities once the CE mark has been granted, update requirements, and more.
You Got CE Marked – What’s Next for your Medical Device? Read More »
EU MDR Readiness Checklist
Clin-r+ Ltd can assist medical device manufacturers with gap assessments and the transition to MDR. An EU MDR Readiness checklist can assist in efficient planning. It should be a practical tool that ensures you are compliant with the regulations.
