Getting ready for the MDR is a demanding process. Whether you are upgrading your existing regulatory structures to the new MDR standard or building fresh systems for a new device, meeting the demands of the MDR can be a challenge even for experienced regulatory specialists.
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Much of the challenge, however, comes not just from the work itself. The sheer volume of work required means that regulatory departments can feel severely under-resourced. So much time is required for every individual work element that it is commonplace for regulatory departments to exceed capacity and become entirely overwhelmed.
This can be a difficult problem to solve because there may be a recognition amongst management that the issue is temporary — once systems have been updated to the MDR standard, workload can be expected to reduce as it focuses more on maintenance than re-engineering. Coupled with a shortage of regulatory specialists in the marketplace, this makes permanent additional recruitment difficult in many cases.
The answer
The answer is to bring in outside consulting support. Expert medical device regulatory consulting services give you MDR specialists who will help facilitate your MDR transition. By their nature, consulting services are intended to step in when needed and then to step away, making it an efficient and cost-effective way of meeting MDR transition requirements without needing to permanently expand your regulatory department. More and more medical device manufacturers are looking to specialist medical device consulting providers for the support they need during their MDR transition.
At Mantra Systems, we go beyond standard regulatory consulting. We have a team of dedicated and specially trained MDR-experts who are also clinically-trained medical professionals. This unique blend of skills means that our consultants combine MDR & regulatory expertise with the clinical acumen needed to meet MDR requirements for clinical evidence generation, appraisal and analysis. Whether it’s writing Clinical Evaluation Reports, designing and implementing PMCF studies & surveys, performing systematic evidence analysis or working with medical device software (SaMD), our team can help.
Contact us today to start your MDR transition.
