Practical Medical Device QA and RA solutions when you need it
At Practical QA/RA we provide Medical Device Quality Assurance and Regulatory resource only when you need it.
Why Practical QARA?
Practical QARA founded to ensure the correct QA/RA requirements are considered at the right time and to simplify and help navigate the waters of regulation. We also have the experience to help address any audit actions
Meeting QA and RA requirements can be challenging and derail timelines. To minimise this we will;
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Help you identify the requirements and pitfalls targeted to your specific device​
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Together we will build a sound effective and compliant Quality Management System, avoiding a burdensome system that will bog you down
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​Help you identify potential defects in the device system process and clinical risks earlier on therefore avoiding time delays
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​Here's why we are different
Put simply, Experience.
That is, 25 years experience in the real world with many companies, large and small, with many devices. We have seen devices get out into the world and do great, we have seen devices flop due to either not getting regulatory approval or failing in the field, and we have seen devices that get a long way through the design process only to discover it isn’t what the customer wants or is unusable.
We have seen the good, the bad and the ugly, ridden the highs and experienced the lows. With over 25 years of Quality and Regulatory experience in various organisations and 25 years of Clinical experience we see both sides of what makes a device compliant, safe, effective, and commercially viable.
Why 'Practical' QARA?
Practical QARA, aptly named as we believe that our combined QARA and Medical experience will enable practical solutions that are based on device, process and clinical risk.
Knowing the regulations is one thing, knowing how to apply them in a pragmatic and practical manner is another. This only comes with experience.
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We bring theory into practice by utilising this experience and our own research to help you determine the most practical route.​​​
We offer:
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Plain and simple advice in order to comply and have a successful product
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Experience in working with startups
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Our expertise in training
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Experience in research, risk analysis and evaluations
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A way to bridge the gap between theoretical and real world scenarios
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Committment to working with you to deliver practical solutions and build lasting relationships with our clients. Collaboration is fundamental to success. We value teamwork and open communication, working closely with our clients to achieve shared goals and mutual success.
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Availability for on-site visits. ​Based near the innovation hub of Cambridge, we can easily be on site at short notice with no travel costs incurred. We also have a base in Scotland. Visits further afield nationally and internationally can be arranged.
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A no fee initial enquiry service to help you ascertain if our services are right for your business. If they are not we will help to try to find someone who is.
Services
01.
Fractional Quality Assurance and Regulatory resource
If you are a start-up and not yet in need of a full-time QA and/or RA resource then we can provide resource from a few hours to a few days per week to setting up an entirely certified QMS and compiling technical documentation and regulatory submissions. We have experience in many global jurisdictions including EU (MDR/IVDR), FDA, TGA.
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We can also offer clinicial reviews as required to ensure your device is, and remains clinically viable through the development process.
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Equally, if you have no idea what you may need, contact us and we will help you.
02.
Remediation or Audit Preparation work
If you have had a bad audit and have corrective actions within your QMS or submission documents to resubmit we can help.
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With expertise in Root Cause Analysis, risk manangement and corrective actions we can help address any issues that are found.
We are also able to provide an independent review of any current documentation or processes.
03.
Quality, Regulatory and Clinical Consulting
We provide strategic business consulting services to help organisations optimise their QA and/or RA operations.
We offer
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Ad-hoc or ongoing advice
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Document preparations such as;
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Risk assessments/reports,
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Clinical assessments/reports
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Literature research
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PMS
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Problem solving
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Independent auditing
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Training (Risk, ISO13485, GMP)​
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​If your organisation is in need of a clinical resource we can also assist.
04.
Manufacturer Person Responsible for Regulatory Compliance (PRRC), UK Resonsible Person Services.
We are able to offer MDR and IVDR Manufacturer PRRC service to micro and small manufacturers as per Article 15.
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For manufacturers based outside the EU we are able to act as a designated UK Responsible Person.
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We are also able to offer a New Zealand Sponsor service for device registration on the WAND database.
05.
Independent Auditing and Technical Reviews
In most start-ups everone is involved with everything - as it should be. Many SME's struggle to find someone who is truly independent to audit specific areas as is required by QMS regulations.
​We can help plan, conduct some or all of your internal and/or supplier audits. Being independent we will see things as a regulator would likely see them. ​​
In start-ups you can get too close to what you are doing and not see the wood for the trees so having an independent review of technical documentation is important.
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06.
Independent Design Reviewer
Similar to auditing, having that Independent Design reviewer is not only a regulatory requirement but also makes sense. Too often companies have an independent reviewer who is merely there to tick a box without realising this approach could come back to haunt them. Independent reviewers need to be exactly that, independent, and not be afraid to ask questions that may not be obvious as this is exactly what a regulator will do.
