Case Study
MEDICAL DEVICE: “Tackling Major Data Insufficiency Findings from Notified Body Review”
MEDICAL DEVICE: “Tackling Major Data Insufficiency Findings from Notified Body Review”
Introduction: In the dynamic landscape of medical device regulations, a small yet innovative manufacturer recently encountered a formidable obstacle. The submission of their flagship orthopedic device for MDR review resulted in major findings of clinical data insufficiency from the Notified Body (NB). Recognizing the need for adept navigation through these challenges, the company sought the expertise of Criterion Edge.
Challenges Unveiled: The intricate examination of the Clinical Evaluation Report (CER) through a meticulous gap analysis by Criterion Edge unearthed a series of pivotal challenges:
Systematic Literature Review (SLR) Methodology Critique:
Competitor Device Search Precision:
Safety and Performance Objectives (SPOs) Realignment:
Strategic Responses Deployed: A collaborative partnership between Criterion Edge and the client paved the way for targeted and effective responses to the identified challenges:
SPOs Redesign for Precision:
Precision in Competitor Device Search:
Navigating the Regulatory Seas: The outcome of this collaborative endeavor was nothing short of a triumph. The concerted efforts between the client and Criterion Edge, demonstrated in the strategic updates to the CER, were met with approval during the second round of NB feedback. This success not only addressed the NB's concerns but also highlighted the resilience and adaptability essential in overcoming regulatory challenges.
In Retrospect: This case study serves as a testament to the intricate dance between regulatory demands and strategic responses. It underscores the vital role that specialized expertise and collaborative partnerships play in steering medical devices through the intricate seas of regulatory compliance.
Conclusion: In the realm of medical device regulations, the journey is often fraught with challenges. Yet, as exemplified in this case study, strategic collaboration and meticulous guidance from Criterion Edge not only led to overcoming the hurdles but also illuminated a pathway for future successes in the complex regulatory landscape.
With over 4 decades of regulatory writing experience and thousands of gap analyses produced, Criterion Edge not only provides experienced writers with PhDs and MDs, but also expertise in regulatory writing best practices, methodologies, and technologies.
Criterion Edge is a focused service provider, delivering medical/regulatory writing and clinical safety services to the pharmaceutical and medical device industries. The company’s expertise in regulatory writing and safety, honed over decades, utilizes best practice processes, produces superior deliverables, and provides budget, resource and timeline flexibility for clients. Criterion Edge empowers companies to deliver superior health care solutions.
Criterion Edge management has over 40 years of industry experience in the pharmaceutical, medical device, and in vitro diagnostics regulatory space.
All our medical writers and quality-control experts are trained to industry best practices, and kept current on changing global regulatory guidelines.
We have developed state-of-the-art templates, tools and analysis practices to quickly identify the root cause of quality issues, and implement solutions for our clients.
Allows each member of the team to concentrate on an area of expertise finding quality writers.
Removes geographic dependence in finding quality writers.
Designed by writers, for experienced medical writers, reducing turnover to nearly zero.