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.
The publication of the new risk management standard BS EN ISO 14971:2019 - Application of risk management to medical devices imposes more stringent requirements on the performing of structured risk analysis than ever before.
Mantra Systems has the benefit of personnel with extensive experience working across the industry in supporting and delivering risk management documentation.
Choosing Mantra Systems as your Medical Risk Management partner allows you to conduct a balanced medical risk management process that ensures full compliance with regulatory obligations.
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.
Ensure that expenditure on expanding your clinical evidence portfolio is targeted to those areas of most critical need. Our clinical expertise will identify important deficiencies in your clinical evidence portfolio and advise how to correct them in the most cost-effective manner possible.
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.