EU MDR Readiness FAQ
What steps should be taken to prepare for compliance with EU MDR
How do you formulate a project plan?
How do you review Technical Documentation structure for EU MDR or IVDR?
We have the answers to these questions and more…
Quality Management System
Systematic Literature Review (SLR) FAQ
Why do you need a systematic literature review?
What steps are involved?
What are some key reasons for non-conformances in literature reviews during audits?
We have the answers to these questions and more…
Quality Management System (QMS) FAQ
What is a Quality Management System (QMS)?
Why is it important?
How does it work?
We have the answers to the questions and more…
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.
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.
