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.
Why is sustainability important in medical device development and manufacturing?
What impact does it have? What is important to consider?
Read for the answers…
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.
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.
The WHO vision for an environmentally sustainable health system is one that improves, maintains, or restores health, while minimizing negative impacts on the environment and leveraging opportunities to restore and improve it, to the benefit of the health and well-being of current and future generations. CLIN-r+ looks into sustainability assessment and what this means for manufacturers.
Sustainability Assessments – Future Impact on Medical Device QMS Read More »
Sustainability is a pressing matter that medical device developers and manufacturers need to embrace, but it is not straightforward. This paper looks at where we are now, and what it means for manufacturers and the design of their medical devices.
What are the EU MDR requirements for device design?
How does it affect your QMS? What changes are needed?
Read on to learn more…
What is the purpose of Instructions for Use (IFU)?
What does it need to include?
How do you create MDR compliant labels?
We have all the answers…
What is EUDAMED?
What’s its purpose? What information does it store and how?
Read on to learn more…
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 »
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