The new MDR compliance challenge
Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.
It is clear to the whole medical device industry that MDR requires more clinical evidence than ever before. However, on an individual company basis it can sometimes be difficult to determine exactly where deficiencies in a clinical evidence portfolio may lie.
Getting this wrong could mean consumption of finance and resource on research that is not needed and does nothing to aid MDR-Compliance.
A modest investment in a Mantra Systems Clinical Evidence Gap Analysis could help ensure that all money subsequently spent on clinical research is appropriately directed and commercially sound.
We will design and deliver Real World Evidence (RWE) Generation Systems in the form of a Medical Device Product Registry that will enable your company to generate RWE in a way that complies fully with all relevant legislative and regulatory obligations including MDR, GDPR, ISO 13485, ISO 14971 and ISO 14155.
The CER is an essential component of every medical device regulatory submission. New regulatory obligations imposed by MDR mean it is more challenging to draft technical documentation. We are highly experienced in drafting CERs in accordance with MEDDEV 2.7/1 rev 4 and guarantee your CERs will be fully MDR compliant.
The publication of the new risk management standard BS EN ISO 14971:2019 - Application of risk management to medical devices outlines more stringent expectations for the performance of structured risk analysis than ever before.
The effective processing of complaints is a central component of any effective medical device Quality Management System. Complaints are a crucial source of information about the performance of medical devices in real use and we will ensure they are handled to the highest professional standard.
Our expertise in handling and assessing Medical Complaints, analysing clinical evidence gaps, performing risk analysis and building RWE Generation Systems allows us to be your holistic Post-Market Surveillance System generation partner.
A properly structured analysis of a competitor's clinical evidence portfolio can reveal opportunities for significant competitive advantage and can give indications as to where their products are failing to meet market expectations.
Generating clinical data is expensive and time-consuming. While the primary objective in doing so may be to ensure MDR compliance of your devices, Mantra Systems can ensure that your sales team can effectively use this data to support sales calls.