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.
Specialized Expertise
Regulatory Guidance
Customized Solutions
Strategic Market Entry
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.
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.
Accelerating Medical Innovation with AIM
At PBC Biomed we believe that Medtech innovation must be accelerated. We have developed a model designed to accelerate the journey from idea to commercialization, while reducing risks along the way. Our Accelerating Innovation Model (AIM) provides a structured roadmap for every project—whether it involves internal IP, client collaboration, or consultancy—always keeping patient wellbeing as the ultimate goal.
How can PBC Biomed help you?
Innovation
Do you have an idea that could improve patient’s lives, but need a partner to bring it to market?
Consultancy
Are you in Medtech and need consulting support to hit timelines and budget?
Manufacturing
Do you need an experienced contract manufacturer that can offer ISO-13485 certified facilities and services?