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Strategic Regulatory, Quality, and Clinical services for medical device companies to promote compliance and to accelerate commercialisation in today’s fast-changing medical marketplace

Consultancy

Our Consultancy Services

To overcome resource, budget, or expertise challenges, Medtech companies increasingly outsource non-core functions. PBC Biomed offers regulatory, clinical, quality assurance and commercial support, to promote compliance and to accelerate commercialisation in today’s fast-changing medical marketplace.

Regulatory

Navigating complex regulatory landscapes is one of the greatest challenges for medical device innovators. We help companies ensure that their technologies meet global compliance standards; accelerating approvals and reducing risks throughout the product lifecycle. We map regulatory strategies, manage existing files and agency interactions, and can act as Authorised Representative and/or Marketing Authorisation Holder on behalf of our clients.

Pre-Clinical /Clinical

We support the remediation of clinical evaluation plans and the preparation of clinical evaluation reports, alongside conducting detailed clinical evidence gap analyses. Our services also include biocompatibility and patient safety support, covering the design of biological safety assessments for ISO 10993 compliance, auditing safety documentation, and coordinating biological testing activities with external partners.

Clinical Affairs Writing

MDR Clinical Evaluation Plan and Report (CEP and CER) Writing for Medical Devices in the EU Market:
Whether your device is a new device to the EU market pursuing a CE mark for the first time or is a device on the market for a long time looking to retain CE marking, PBC Biomed’s clinical affairs writing department can help you identify what’s needed and provide assistance in achieving a successful submission. Services offered include:
Experienced CEP and CER Authors: including health care professionals, writers with advanced qualifications such as MSc and PhD who fully satisfy the requirements for the requirements for MDR 2017/745 with EU Notified body experience in Class I, II, III medical device conformity submissions.
Experienced clinical experts (MD) to act as CEP and CER Evaluators

Commercialisation

With offices in Ireland, France and the US, our commercialisation team works closely with clients around the world to conduct a thorough Business Opportunity Analysis on their proposed technology. We examine the market, obtain feedback from a global panel of prominent clinical advisors, and design robust go-to-market strategies to maximise impact upon launch.

Stay informed on our latest clinical milestones, white papers, and the evolving landscape of medical device technology.