Brightbark Cranberry exists to help medical device businesses navigate regulation with clarity and confidence.
OUR MISSIONOur approach, informed by direct experience of how notified bodies think, is to understand your regulatory position fully; solving the problems you know about, and revealing the ones you don't. Our consulting and training are designed so that you're never starting from scratch again.
Regulatory Affairs is an unseen key to competitive advantage.
OUR PHILOSOPHYRegulatory affairs (RA) is often seen as an overhead. But used correctly, it is a powerhouse of commercialisation.
We’ve argued that RA teams have some of the most comprehensive competitor analyses in a business, but they’re never seen by commercial decision makers. RA can drive your decision to make or buy; decreasing downstream costs through the best compliance choices. Most critically, a well resourced RA department can give your marketing team clear costs and timelines to get a device to market in a particular country. Most companies don’t connect the dots between functions, leaving regulatory and marketing teams siloed.
We’ve also argued why RA is not just a support function, and should have a seat on the board. If you work with us, a theme in our management consultancy is to align authority with accountability for RA. The benefits are clearer awareness of critical regulatory issues at board level, better organisational preparedness, and enhanced inter-departmental communication.
Technical debt is clearly seen by RA, when bringing together multidisciplinary inputs for a submission or audit. What’s the issue with technical debt for senior leaders? Opportunity cost. The more time your development, manufacturing and quality teams spend making up for historic issues, the less time they’re spending on new ventures. Getting inputs to regulatory submissions right first time, and structuring teams to give RA the right authority, is the start of correcting technical debt in medtech companies.
OUR APPROACH
Personal Service
Responsive Communication
Timely Soutions
Customer Service
For Brightbark Cranberry, customer service is paramount. We are a small consultancy, with the time to work closely with each customer.
From your first enquiry with us, we will respond personally and promptly, making time to follow-up to clearly understand your needs. Throughout a work package or project, we will offer check-in appointments, and provide appropriate updates by email or meetings. We deliver on-time, and meet with you to explain the deliverables.
Bespoke Solutions
We have the knowledge from design, manufacturing, quality, regulatory and business management to draw together holistic solutions. Our recommendations aren’t based on isolated regulatory experience - they balance needs from across the med tech business.
We also know that timing is key. A well-formed solution delivered in three months is better than a theoretically perfect solution delivered in five years. Our recommendations enable you to solve problems now and lay groundwork for the future.
Client Journey
Every engagement is bespoke, and every contract is tailored.
We put great emphasis on fact-finding, determining your goals and needs, before issuing a proposal.
Some clients have a very clear scope of works - for example a submission component - in which case we can often issue a fixed price proposal.
Other clients might have an idea of an issue, but want a more fundamental investigation before committing to a solution. In those cases we can bring together all three segments to analyse the organisation’s current performance, providing a further proposal of solutions.
Our People
Joseph Langley MEng CEng MTOPRA
DIRECTORSuccess in your regulatory submissions is built on skills and experience - and we can be your partner to provide them.
Joseph is a former BSI Notified Body technical specialist, with nearly seven years as a technical expert for orthopaedic and dental devices, and a career spanning manufacturing and quality, research and development, regulatory affairs and management in the medical device sphere.
He approaches regulatory work through a commercial lens, treating regulatory success as inseparable from business success. His technical and regulatory recommendations are consistently connected back to the underlying business case.
Joseph combines close attention to technical detail with awareness of the broader commercial and strategic picture, bringing this problem-solving approach to every new engagement.
GENERALISMSAll aspects of EU MDR, EU IVDR, UK Regulations. ISO 13485. Design control. Risk management & ISO 14971. Labelling and IFU. eIFU. Verification & validation, mechanical testing. Regulatory strategy, submission strategy. Notified body interactions. QMS & procedures. Post-market processes. Supply chain compliance. Certificate management. Audit approach.
SPECIALISMSSmall & large total or partial joint replacements, orthopaedic trauma, sports medicine devices, limb salvage, surgical instruments. Biological evaluation and clinical evaluation for implantables and general devices. Verification & validation for orthopaedic, dental, general devices.
QUALIFICATIONS & ACCREDITATIONSAdvanced Apprenticeship, Mechanical (Manufacturing) Engineering, Corin Group
Master of Engineering, Mechanical Engineering, University of the West of England
PGCert*, International Management & Leadership, Queen Margaret University *Equivalent - studying to higher level.
Chartered Engineer, Member of the Institution of Mechanical Engineers
MTOPRA, Registered Member of The Organisation for Professionals in Regulatory Affairs