CONSULTING RA MANAGEMENT
PROCEDURES CONSULTATION
SET A PATHWAY AND GUARD RAILS
Good procedures are built around how work actually happens, not how it looks on paper. Whether you need a full suite developed from scratch — for a start-up or scale-up without an established QMS — or a structured gap assessment of existing documentation, we review against applicable legislation, standards, and guidance, and examine whether defined responsibilities reflect real practice.
The output is procedures, work instructions, and forms that do what they are supposed to do.
Quality manual
Risk management and risk analysis
Design control
Verification and validation
Biological safety
Clinical evaluation including state of the art, literature search, evaluation of data
Post market surveillance (PMS)
Post market clinical followup (PMCF)
Complaint handling
Incidents and FSCA
MDR / IVDR gap assessment
OPERATIONAL MODEL CONSULTATION
DO YOU HAVE THE RIGHT FUNCTIONS AND ORGANISATION?
Regulatory affairs is more complex than ever - it’s not just pre-market and post-market anymore. Skills have become more specialist, in response to the increasing complexity of the regulatory environment.
We can evaluate your current organisational structure, compare it to external benchmarks and industry practice, and make recommendations for capability and efficiency, both now and aligned with your business plans.
Does your team have…
the right skills and experience for the device type?
sufficient clinical knowledge?
biological safety expertise?
sufficient expertise to make registrations around the world?
How well does your team work with…
quality functions?
product development?
manufacturing?
external partners?
PEOPLE CONSULTATION
GROW YOUR PEOPLE, CAPABILITIES AND CAPACITY
Working from the evaluation of your department’s structure, we can make recommendations for the future of roles and responsibilities.
We believe that providing structured career paths and aligned training plans empowers your team members to develop themselves, delivering you a more capable and efficient team; and better retention.
We can help…
Define career development pathways
Create a matrix of expected knowledge and skills for each role, aligned with external standards
Create aligned job descriptions
Create training plans for each role
Focus on empowering staff to be responsible and accountable
FRACTIONAL LEADERSHIP
WHEN YOU NEED ENOUGH - BUT NOT TOO MUCH
Most medical device start-ups reach a point where regulatory affairs can no longer be managed informally — but are not yet at the scale where a full-time senior hire makes commercial sense. A fractional Regulatory Affairs Manager provides the strategic direction and functional oversight the business needs at this stage, without the overhead of a permanent appointment.
From the earliest stages of product development, having experienced regulatory input shapes decisions that are difficult and costly to unpick later — classification, clinical strategy, the structure of your technical file, your choice of notified body. A fractional engagement brings that experience into the business on terms that fit where you are now, not where you will be in three years.
NPD PROCESS FLOW CONSULTATION
GET TO MARKET FASTER
New product development (NPD / NPI) is your route to growth, and time to market is the timer on your revenue.
Yet so many companies use a series of disjointed procedures to develop new products - design control doesn’t fit neatly into project management, quality and manufacturing work in separate silos, and marketing dip in and out.
It doesn’t have to be like this - an end to end review of your new product development processes can highlight ways to work more collaboratively and more effectively.
We can help…
review & recommend improvements to organisational structure and roles
analyse & recommend improvements to NPD procedures
find and remove roadblocks in procedures
highlight and remove conflicting requirements
DUE DILIGENCE SUPPORT
KNOW THE RISKS BEFORE SIGNING THE DEAL
Regulatory affairs risk is rarely visible on a balance sheet, but it can determine whether an acquisition creates or destroys value. A legacy device portfolio with poorly maintained technical files, unresolved non-conformities, or a transition timeline that has slipped represents real commercial exposure — and the kind of exposure that standard financial due diligence is not equipped to find.
We support acquirers and investors with regulatory due diligence on medical device targets: reviewing technical file quality and completeness, assessing QMS maturity, identifying non-conformities and remediation burden, and forming a view on the regulatory risk profile of the device portfolio as a whole.
CONTRACT MANAGEMENT RESOURCE
Interim or temporary management of teams, projects or portfolios.
Full time or part time.
Any duration.
SOMETHING ELSE?
There’s a lot of other things that Iwecould help with.
If it’s not listed above, get in touch - we can have an open ended conversation.
We’ll never sell you a service that you don’t need.
Why Brightbark Cranberry for RA management consulting?
Joseph Langley MEng CEng MIMechE
I have a career spanning manufacturing & quality, research & development, and regulatory affairs, including nearly seven years as a technical expert for orthopaedic & dental devices at the BSI Notified Body.
My wide range of reference points and my approach of always seeking improvement and growth directly translate to management consulting. Where there’s improvements to be made, I’ll help you find them.
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I’ve manufactured hip and knee devices - on mills, lathes, polishing machines. I’ve packaged devices by hand. I’ve designed devices from concept, and tested them to destruction.
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BSI provides training to it’s product experts that is second-to-none. I have expert level knowledge of EU and UK regulation, and in depth knowledge of international standards that support global regulatory regimes.
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As early as my apprenticeship, my employers favoured my approach to problem diagnosis and solutions. I’m not afraid to point out the elephant in the room. I’ll never stop seeking improvement. But for success, you must always bring it back to the business case.
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People are the centre of any business - whether you sell services or products. If they are well trained, with clear procedures, the market is yours for the taking.