Having started my working life in 1984 as a mechanical engineering technician, specialising in Quality Assurance under BS 5750, my first medical device quality role was in 1991 with a company manufacturing electric suction devices for hospitals and clinics. It was an exciting time to be working in the medical device industry with the introduction of the Medical Devices Directive (93/42/EEC) in 1993 and the evolution of EN46001 into ISO 13485.
As my career progressed I worked with companies that manufactured operating theatre suction devices, asthma inhalers, syringes, infusion pumps, syringe drivers, medical lasers, orthobiologic devices, orthopaedic implants, breast implants, gastric bands and balloons, dermal fillers, IVD devices and reagents, and a variety of Software as a Stand-alone Medical Device products. Products from device Class I through to Class III.
My roles encompassed Quality Management, Regulatory Compliance and Post Market Surveillance for products marketed around the globe. I hosted Notified Body and Regulatory Authority audits and inspections and represented the interest of a major manufacturer in the global breast implant market during the PIP Breast Implant investigation and analysis by the European National Competent Authorities.
At the end of 2014 I decided to step away from the world of global corporate medical device manufacturing and set up my own business, offering consultancy services to medical device start-up companies. I had identified a need for these small enterprises to be able to tap into a flexible resource for quality and regulatory advice and activities from the early days of establishing themselves.
My first few projects involved the acquisition and transfer of CE mark for Class IIa devices, post FDA inspection QMS remediation and preparing a business for their ISO 13485 certification audits. I then took on couple of interim posts as contract Quality Manager and Regulatory Affairs Manager.
WELCOME TO SHELLEY QUALITY MANAGEMENT SERVICES LTD
Founded in January 2015 by Samantha Shelley, Shelley Quality Management Services (SQMS) Ltd. has the benefit of over 25 years of experience in medical device quality management system and regulatory compliance covering products from Class I to Class III.
We incorporate a pragmatic approach with career-long experience in successfully implementing Quality Management Systems to provide a bespoke solution for every client.
To provide medical device start-ups with a flexible and cost-effective quality and regulatory resource enabling them to successfully negotiate the quality and regulatory hurdles and get their product to market.
A favourite quotation of mine comes from C. S. Lewis: “Integrity is doing the right thing, even when no-one is watching”. In medical device manufacturing integrity is key. Patients and users of medical devices expect the manufacturer to have complied with all of the standard and regulatory requirements and their device to be safe and effective.
SQMS will work with you to build a QMS that matches the culture of your business whilst also meeting the requirements of ISO 13485 and the appropriate regulatory requirement. The effectiveness of the QMS comes from its implementation within the business and the integrity of the people delivering those processes day in, day out.
We always take a pragmatic approach when it comes to creating the QMS, reducing bureaucracy to the minimum, whilst ensuring that compliance to the regulatory and standard requirements is robustly achieved.
We can provide the following services for your medical device business:
QUALITY MANAGEMENT SYSTEM
Helping you to create a QMS that fits with the culture and style of your business, enabling consistency of process delivery without stifling creativity.
Partnering you through the certification process with your chosen Notified or Certification Body, including training your employees in what to expect and how to behave.
Providing remediation guidance and resource following an unfavourable audit or inspection.
Delivering training on key QMS processes and skills such as root cause analysis, risk management, feedback/complaints and vigilance/post market surveillance.
Carrying out your internal audits, identifying improvement opportunities for the procedures and guidance on how to increase employee compliance.
Determining device classification and applicable regulatory requirement.
Creating regulatory strategy to take product to market in the chosen country(ies) and region(s).
Compiling the technical file in reparation of submission.
Assisting with the submission process, product and site licensing/registration.
Preparing for and hosting Regulatory Authority inspections and working on remediation activities.
Cognidox is an affordable and flexible eQMS platform built on a document management system with a lean approach to design controls and quality compliance. With Cognidox, document control, workflow automation, quality modules, compliant e-signatures and software validation comes as standard, and they have a proven track record of helping innovative companies scale and succeed.
Motilent Ltd have worked with Sam Shelley of SQMS Ltd as a contract Quality Management Consultant for the past 18 months. With the help of Sam, Motilent have been successful in obtaining ISO13485:2016 certification and a CE mark for our class IIa software medical device from British Standards Institute (BSI).
Motilent are delighted to work with Sam, who has brought invaluable experience and wisdom of quality systems and the medical device sector to our company. Motilent continue to work with SQMS for internal audits and company improvements as we grow and place our products on the market.
Dr Russell Pearson
Operations Lead at Motlient Ltd.
We have been delighted by the work you have taken out for us so far in relation to providing us contract quality management services, including QMS transition to ISO 13485:2016, internal auditing and hosting the certification audit with our notified body.
It has been an absolutely pleasure to work with you so far and I am looking forward to working with you in the future.
CEO and Co-Founder of mOm Incubators Ltd.
We supply important eye care instruments to the NHS, as a company we count on Samantha Shelley of SQMS Ltd to keep us in check with the latest challenges and changes to our ISO certification standard 13485:2016
Sam does our internal audits and really all credit goes to Sam in getting my team to make the best of our ISO systems, Sam is also QMS manager and very much hands on like our own employee.
Sam is very approachable and goes the extra mile; no task is too small or big. Thank you Sam of SQMS and keep up the excellent work.
Managing Director of Sense Medical Ltd.
MOBILE: 07711 362462
EMAIL: sam(Replace this parenthesis with the @ sign)sqms.org.uk