Welcome to PMF Consultants’ web site. We aim to offer a helping hand to small businesses.
We do not use a “one-size fits all” template solution to your particular problem.
Rather, we are small, agile and experienced enough to craft a tailor-made solution to your particular requirements.
We pride ourselves in using previous experience not as a “cut and paste” answer,
but as a source to bring novel solutions from one industry into another.
Between us, we have experience in such a diverse array of industries as ship-building, aircraft maintenance,
medical devices, pharmaceutical, construction, education and catering/hospitality.
We have also experienced life from the shop floor to the board room; and so feel that we can offer solutions that
will really work in your business and stand the test of time, not just be a temporary imposition that fades away.
We can provide services in the following areas:
• Engineering project management
• Medical device regulatory applications (CE Marking & FDA 510(k))
• Quality Systems: ISO13485, ISO9001, MDR and internal audit
• Payroll & Accounting
• Office Management
Choose the appropriate option from the menu to find out more.
• Compile Project Definitions.
• Design test schedules.
• Document designs.
• Write User & Technical Manuals.
The success of a project is laid in the detailed planning,
though it is natural to want to get straight on with the nuts and bolts of it once you have had the idea.
We can help you with the formulation and monitoring of your project; and leave the fun part, the design, to you!
Areas where we can assist:
• A precise and detailed project definition is key - you then know what you are trying to do.
• A thorough test plan to prove that you have been successful in the design.
• Assistance with regulatory (CE Mark) compliant design.
• Drafting user and technical manuals. An outside viewpoint is often very helpful in ensuring that the information is comprehensive and easy to understand.
• Design ISO9001 & 13845 procedures.
• Compile Medical Device Technical Files.
• Write FDA 510(k) submissions.
• Product design specifications & verification testing.
You want to get on with turning your good idea into a product.
The R&D part is exciting, the regulatory part is not.
With over 20 years of experience in the medical device industry,
we can assist with the compilation of CE MDR-compliant technical files
and advise on risk analysis and essential requirements checklist formulation.
We could also assist with your FDA 510(k) submission, from selecting the
most appropriate predicate, all the way through to drafting the complete
submission for you.
The dividing line between medical and consumer or “life style” devices is
becoming increasingly blurred and is evolving differently in FDA and CE jurisdictions.
Careful design and control of the feature set can keep a device out of the medical arena,
with a different, simpler route to market. The regulatory requirements are very different
in the US and Europe; early advice on regulatory strategy can make your route to market
much easier and cheaper.
• Design ISO9001 & 13845 procedures.
• Pre-compliance audits.
• Internal maintenance audits.
• Design quality objectives.
Every one agrees that quality is a good thing, but often you don’t have time for it,
just yet. We can take the pain out of implementing an ISO9001:2015 and ISO13485:2016 quality system in your business.
The core principle of our approach is to make a system that is tailored for you, not re-use a template solution.
In that way, the quality system will become to be seen as an integral part of your business,
not just an encumbrance that is added on just so that you can tick the "ISO9001 box".
If you are wondering about the cost of having a quality system, think of it like safety:
It is not the cost of doing it that is important, it is the cost of not doing it that really can hit you.
How many times have you accidentally supplied the wrong thing to a client?
Do you depend upon a couple of individuals in a company to see that things are right?
• Book keeping to trial balance.
• Staff hours.
• Invoicing, credit control.
• Management information packages.
If your accounts are tasks that divert you from,
or take second fiddle to the day-to-day running of your business;
then we could help by supplying a few hours per week in you premises to keep your invoicing
and monthly accounts up to date. With many years experience in both Sage Line 50 and QuickBooks packages,
we can free you up to do what you really want to do - run the business.
We can also provide you with vital management information on the health of your business:
cash flow, P&L, accruals required, profit margins on various activities.
All work carried out in the strictest of confidence under a mutual non-disclosure agreement.
• Draft office procedures.
• Clear filing backlogs.
• Run training programmes.
• Set up databases.
Do you seem to waste a lot of time in meetings, can you never find that important document or piece of information?
If so, then perhaps you need a little help with generating some simple procedures and standard working methods to ensure
that everything has a place and everything is in its place.
We can help with simple forms, records and procedures that will make your life easier,
not more bureaucratic and can give you and your staff some training to make your meetings
and phone calls much more productive.
Some examples of our clients:
Medical Device Products: Various roles in project management, compile CE Mark Technical Files, FDA 510(k) applications,
labelling and manuals for ECG, Sleep Apnea, Bruxism, Defibrillation, Neonatal EEG and cleansing/disinfection and wound management products.
Quality: Write ISO9001, ISO13485 & MDR compliant quality systems.
Advise and front company response in CE and FDA audits.
Gap analysis for products developed as pharmaceuticals, but regulated as medical devices.
Gourmet Pub, NI: Book keeping.
Subsidiary of Multi-national, NI: Technical author for high-voltage transformer monitoring equipment.
Pharma Companies, UK: GMP, office management, drug licensing and import, addition of ISO13485 for Software as Medical Device (SaMD).
Architects Office, NI: ISO 9001 internal audits, office management.
Medical Device Company, UK/USA: transition to new US company on acquisition.
+44 (0) 7789 633 508
+44 (0) 2891 884 309
PMF Consultants is a private limited company, incorporated in Northern Ireland. Company# NI073145.
Registered address: 10 Vail, Donaghadee, Co Down, BT21 0QL