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 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.
This case study looks at remediating a problematic Clinical Evaluation Report and how CLIN-r+ supported one manufacturer when they decided to outsource EU MDR Clinical Evaluation and Investigations.
Clinical evaluations are an essential component of the EU MDR and IVDR. Clin-r+ discusses the cost of clinical evaluations in 2023, what you can expect to receive at both ends of the range, and what you should be paying for.
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.
Clin-r+ wants to assist manufacturers to understand the state of the art and provides guidance to help explain what it is and how it can help make your CE submission successful.
Manufacturers can circumvent the time and expense of conducting clinical studies to satisfy the safety and performance requirements as outlined in the clinical evaluation by claiming equivalence with another device to get CE certification under the MDR.
MEDDEV 2.7/1 Rev 4 is a Clinical Evaluation guide for manufacturers and notified bodies and the MDR provides further information on the clinical data requirements. CLIN-r+ explains the key stages of clinical evaluation and what documentation you need.
The Clinical Development Plan (CDP) is a new document that you must complete for the EU MDR Technical Documentation. Clin-r+ explains how it’s an important strategic document that can help MedTech align development and regulatory requirements.
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