CONSULTING REGULATORY AFFAIRS
REGULATORY WRITING
WRITE DOCUMENTS RIGHT
Writing of an entire submission, or just parts.
We have experience with all aspects of regulatory submissions for implantable and surgical devices, from labelling and IFU, through design control, risk management, verification & validation, packaging validation, transit validation, shelf life validation, biological safety, and clinical evaluation.
Our experience is instrumental for EU and UK submissions, but the same principles and standards underlie most international regulations.
Regulatory plans
Classification rationales
Requirements checklists
Lists of applied standards
Labelling and instructions for use (IFU)
Design control - user needs, design inputs, input/output matrix
Verification & validation planning
Risk management files including risk analysis and benefit-risk analysis
Performance testing protocols and reports
Shelf life testing protocols and reports
Transit testing protocols and reports
Biological evaluation protocols and reports
Clinical evaluation protocols and reports
CMR (GSPR 10.4) justifications
STRATEGY CONSULTATION
GET ON THE RIGHT PATH, EARLY
Regulatory pathways are complex. Considering multiple products, multiple markets - this adds to the regulatory blur.
Decisions made early in projects can impact regulatory timelines too - each regulator has guidance and expectations for data - particularly clinical evidence.
Our regulatory strategy consultation can help set you on the right path for your start-up, spin-out, NPI/NPD or change submission.
REPRESENTATION TO AUTHORITIES
WE TRANSLATE NOTIFIED BODY SPEAK
Notified bodies speak a particular language.
Sometimes, that doesn’t translate well for technical and scientific staff. Other times, you’re really close to answering the query, but just can’t find the words to justify it in the way they expect.
Through hands-on experience of working at BSI, we know how to get over the hurdles; or when to walk away and close technical gaps.
Applications
Technical documentation reviews
Responding to non-conformities / audit findings
Post market reporting queries
Renewals
SUBMISSION CONSULTATION
NOT SURE IF IT WILL PASS?
Some submissions are just tricky.
We can advise on submission approach, evaluate the submission quality, or perform a full gap assessment with recommendations for improvement and regulatory success.
Extending Indications or patient populations
Shelf life extensions
New materials
Equivalence rationales
MOCK TECHNICAL DOCUMENTATION AUDIT
BE READY
Technical documentation for some device classes is based on sampling. You prepare everything to your procedures, and the Notified Body selects a device to assess.
Why wait until the audit to evaluate compliance? Let us find the gaps before your notified body does.
We’ll even provide a detailed report with recommended actions.
Insights regarding which devices notified bodies are likely to sample
Insights into auditing approach for technical documentation
Find weak points before they surface in audit reports
Get recommendations to make documentation more robust
LARGE CHANGE PROJECTS
ACCELERATE REGULATORY PROGRESS
All business face them from time to time - a change so big, affecting so many products, and with regulatory impact.
We can:
Help you set up the project for regulatory success
Advise on strategy
Drive key deliverables for regulatory submission
Write documentation
Notified Bodies know that these change projects happen, but they expect information to be presented in a particular way. Our experience brings this to you.
Packaging component / process change
Remediation of risk management files
Remediation of design control documentation
Labelling changes (e.g. EU Rep, CH Rep, Distributor, address changes)
Systematic response to audit findings
Overhaul of clinical evaluations
MARKET ENTRY CONSULTATION
EXPAND YOUR DISTRIBUTION
Despite attempts at global harmonisation, international regulatory requirements are as complex as ever.
If you want to market in a particular country, but are not sure what regulation applies and what you need to do to sell there, let us do the leg work for you.
Determine applicable legislation(s)
Clarify route through assessment
Establish registration requirements
Ascertain post market reporting
Source in-country representation
TAILORED TRAINING
UP-SKILL YOUR TEAM
Need to train your RA team but don’t have time?
Need in-depth training on a specialist topic?
Feel that there are some gaps that need addressing?
We can create a single session or multi-session programme to increase your team’s capability.
EU MDR or IVDR legislation, clause by clause
MDCG guidance
How to classify devices
Conformity assessment routes
General Safety and Performance Requirements (GSPRS)
Labelling and Instructions for Use (IFU)
Design control
Verification and validation planning
Biological safety evaluation - planning and reporting
Risk management - theory and application
Clinical evaluation
Post market requirements
Key / specific standards
Writing for notified body assessment
CONTRACT RESOURCE
REGULATORY AFFAIRS WITH NOTIFIED BODY KNOWLEDGE
Hourly, daily, or monthly - book the additional regulatory resource that you need.
Our specialty is EU technical documentation and submissions, but many of the same standards and approaches apply internationally.
Our device experience is a wide range of orthopaedic and dental implantable and surgical devices, from which the principles can be applied to a range of non-active (invasive or non-invasive) devices.
There’s a lot of other things that I could help with.
If it’s not listed above, get in touch - we can have an open ended conversation.
I’ll never sell you a service that you don’t need.
SOMETHING ELSE?
Why Brightbark Cranberry for regulatory affairs 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.
Beyond this I have a curious mind that must be satisfied with the details, whilst also taking into account the bigger picture. I always connect the business case to technical and regulatory work.
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Hands-on experience designing and manufacturing devices brings a grounded approach, that can relate regulatory requirements to operator actions in the factory.
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Insider knowledge of how Notified Bodies work and interact. Experience working with some of the largest orthopaedic multinationals.
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Experience with a wide range of orthopaedic and dental implantable and surgical devices, giving a platform for working with almost any invasive or non-invasive (non-active) device.
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Informed by nearly seven years as a BSI technical documentation auditor; and second-to-none training.