WHY BRIGHTBARK CRANBERRY
Our value proposition
Cost and time effective solutions to regulatory problems.
Integrated problem solving across staff, procedures and products.
Leaving clients more capable and informed.
Regulatory Affairs is an unseen key to competitive advantage.
RA is often seen as an overhead. But used correctly, it’s a powerhouse of commercialisation, akin to marketing.
We’ve argued that RA teams have some of businesses most comprehensive competitor analyses, but they’re never seen by commercial decision makers. QARA can drive your decision to make or buy, if you let it, 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 properly, 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.
We move effortlessly from the big picture to the detail.
Whether that’s from the conclusion of a technical report to an overall submission strategy, or the timing of a deficiency response in relation to a launch plan - we make the connections that drive success.
Three complementary segments.
Used independently, or woven into a bespoke solution.
REGULATORY AFFAIRS CONSULTING
MANAGEMENT CONSULTING
QUALITY & REGULATORY TRAINING
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
BIO
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.
DIRECTOR
QUALIFICATIONS & ACCREDITATIONS
Advanced 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
GENERALISMS
All aspects of EU MDR, EU IVDR, UK Regulations. Design control. Risk management. 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.
SPECIALISMS
Small & 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.