Practical Quality Assurance and Regulatory Affairs Ltd.
We offer Quality Assurance (QA) and Regulatory Affairs (RA) consultancy to medical device and IVD companies. We also offer clinical advice with a Co-Founder being a consultant physician.
With a wealth of experience in start-ups we have seen successes and failures with some attributable to a lack adequate QA and RA input well as a failure to recognise the voice of the customer. We are able to provide fractional QA and RA support on an ad-hoc or ongoing basis without the need for a permanent employee. We offer risk-based solutions that are practical and pragmatic resulting in a least burdensome approach to compliance.
With over 50 years combined QA/RA and Clinical experience we offer risk based practical and pragmatic solutions to suit your needs gained from real world experience in multiple organisations.
Practical QARA was founded by Dr's Stephen Smith and Maria Vella in 2024.
Stephen started his journey in Quality Assurance and Regulatory Affairs in Medical Devices in 1999. Starting as an internal auditor he went through the ranks to being a QA/RA Director leading teams of up to 25 internationally. Over this time he has seen vast changes in technology, regulation, perception and practice. He has gained experience in IVD's and devices ranging from device disinfection solutions to surgical robots and implemented Quality Systems in several organisations. He has experience in placing devices in the EU, US, Australia, NZ, Singapore and many other countries and been audited more times than he cares to remember. He thinks outside of the box to find practical solutions to compliance that are risk-based, pragmatic and more effective. With more than 25 years in the industry both in start-ups and multinationals he has seen things done well, not so well as well making his own mistakes along the way - but learning from each one. He also knows the early warning signs that lead to failure, something that only comes from experience.
As well as a PhD in medical Device Quality Management, Stephen also has a Masters degree in Medical Diagnostics, another Masters in Physical Geography, and a Bachelors degree. He is a Fellow of the Chartered Quality Institute (CQI) - the highest grade of membership awarded for substantial achievement/contribution to the Quality profession, a voluntary member of CQI's Content Advisory Panel, has lectured on QA/RA topics at postgraduate level, is a member of TOPRA, a six sigma green belt, and a trained lead auditor.
See more about Stephen here: https://www.linkedin.com/in/stephensmith02
Maria is a Consultant Obstetrician and Gynaecologist and brings a necessary clinical eye to the table. In her 25 years clinical experience she has seen great medical devices that she has used repeatedly and ones which she has tried once and never used again - whilst also telling colleagues of the experience. Maria knows what clinicians want and what they don't, and most importantly knows what may present a clinical risk which many companies fail to consider, particularly in early stages. Maria completed a two-year research fellowship in Urogynaecology with Professor Linda Cardozo at Kings College Hospital, London, followed by a three-year subspecialty program in urogynaecology. She has a passion for research and has been involved in the publication of many papers which are widely cited. She is often invited to peer reviews has presented at national and international meetings and written a number of book chapters.
Maria received recognition for best free paper in 2006 by the International Urogynaecological
Association, and again in 2012 by the European Urogynaecology Association. She is also a college tutor in charge of trainees in obstetrics and gynaecology.
Read more about Maria on Doctify and Linkedin.
Practical Medical Device QA and RA solutions when needed.
Products and services
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.
We can also offer clinical reviews as required to ensure your device is, and remains clinically viable through the development process.
Equally, if you have no idea what you may need, contact us and we will help you.
Quality, Regulatory and Clinical Consulting
We provide strategic business consulting services to help organisations optimise their QA and/or RA operations.
We offer
- Ad-hoc or ongoing advice
- Document preparations such as;
- Risk assessments/reports,
- Clinical assessments/reports
- Literature research
- PMS
- Problem solving
- Independent auditing
- Training (Risk, ISO13485, GMP)
If your organisation is in need of a clinical resource we can also assist.
Country Representation and Sponsorship
We are able to offer the following services:
- Manufacturer PRRC service to micro and small manufacturers
- EU Authorised Representation though presence in Malta
- UK Responsible Person
- New Zealand Sponsorship with presence in Hamilton (NZ)
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.
With expertise in Root Cause Analysis, risk management 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.
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.
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.