Medical Device Archives

Understanding the 2024 Updates to the ISO 18562 Series for Medical Devices

The ISO 18562 series of standards, which governs the biocompatibility evaluation of breathing gas pathways in healthcare applications, has undergone a significant revision in its 2024 edition. These updates introduce important changes that reflect advancements in testing methodologies, regulatory expectations, and the safety of medical devices.

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UKCA - MHRA update: International Regulation Framework

UKCA MHRA International Regulation Framework

Regulatory Strategy / Clin-r+

On 21 May 2024, the MHRA published a Statement of policy intent: international recognition of medical devices update. This exciting development means that MHRA will start accepting medical devices that already meet EU, USA, Australian, and Canadian regulations with conditions. CLIN-r+ explains the succession of events that has brought us to this point and what the future holds for manufacturers entering the UK market.

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Performance Evaluation for IVDR FAQ

FAQS / Clin-r+

What documents and resources are needed for performance evaluation requirements under IVDR?
What is involved in the performance evaluation process for IVDs under the IVDR?

We have the answers…

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Nonconformities for MDR submissions FAQ

FAQS / Clin-r+

What are common nonconformities identified under the EU MDR?
What does a Notified Body want from your Technical Documentation?
What can mitigate risks and ensure compliance?

We have these answers and much more…

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Intended Purpose, Intended Use and Indications for Use FAQ

FAQS / Clin-r+

Why is the “Intended Purpose” important for medical devices under EU MDR?
What are the key differences between “Intended Use” and “Indications for Use” for medical devices?
What information should be included in statements regarding “Intended Purpose” or “Indications for Use”?

We explain the answers to these questions and lots more…

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EU MDR Readiness FAQ

FAQS / Clin-r+

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…

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Systematic Literature Review (SLR) FAQ

FAQS / Clin-r+

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…

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Quality Management System (QMS) FAQ

FAQS / Clin-r+

What is a Quality Management System (QMS)?
Why is it important?
How does it work?

We have the answers to the questions and more…

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Claiming Equivalence FAQ

FAQS / Clin-r+

What is the difference between claiming equivalence under EU MDR compared to MDD?
What are the key requirements for demonstrating equivalence?
What can improve the process of demonstrating equivalence under the EU MDR?

We answers your questions and more…

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