SQMS Ltd

Contact Details

Address: 
5 Mews Court, Larwood Way, Shipdham, IP25 7LN

A Medical Device QMS consultancy specialising in helping start up companies establish and gain certification of their QMS.

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.

Our Mission

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.

Our Values

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.

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Whether you are looking to grow your business, raise your profile in the local community, network with other Norfolk businesses, trade internationally or raise your (or your staffs) skill level, being a member of the Norfolk Chamber can help you achieve your businesses objectives.

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