ISO 13485 Providers in
United Kingdom
Find verified ISO 13485 Medical Devices Quality Management consultants, certification bodies, and training providers in United Kingdom. Compare profiles, read reviews, and get free quotes — no obligation.
Assent Risk Management is a progressive Risk and Resilience Consultancy built for the digital age. We champion International (ISO), British (BS), European (EN) and other standards that enable global trade, improve organisations and protect societies. Assent Risk Management expert team delivers impartial consultancy and auditing services across multiple disciplines including: information security, cyber security, environmental sustainability, health & safety, quality management and business improvement. More than just box ticking, our team works in collaboration with yours to build bespoke management systems, supported by technology and other products, that return real business benefits.
Kent Safety Solutions is a compliance consultancy firm covering the whole of the South-East of England. We offer cost-effective solutions to Health and Safety and Management Systems, which are vital parts of every business. All of our consultants are Nebosh and Lead Auditor trained, and we always make sure we?re up-to-date on laws and regulations so that you can be confident you?re getting the most recent and correct information.
MQF is?a family owned and managed business with a reputation for client care and excellence. We can implement ISO standards to suit your business without drowning you in paperwork and jargon.We have over 20 years experience of successfully implementing ISO standards and have many long-standing clients who are happy to provide an insight into our methods should you require. Our consultants are registered with IRCA, CQI and IEMA and are qualified auditors.
Heath & Co was established by Tom Heath, the Managing Director, who possesses extensive experience in various industries, including Aerospace, Automotive, Electronics, and Joinery. Tom is certified in Nebosh, IEMA, and as an ISO9001, 14001 & 45001 lead auditor, with remarkable expertise in implementing management systems. Heath & Co Management Services are specialists in all aspects of QHSE (Quality, Health and Safety and Environmental management). Our Expertise: ISO implementation (ISO9001, AS9100, ISO45001, ISO14001, ISO13485) Management system maintenance (Internal Auditing) Health and safety consultancy and training ? Risk assessing, method statement creation, general safety training, CoSHH, Machinery safety Contract auditing Contract QHSE management
Bywater is the UK's leading independent provider of training courses for implementing and auditing management systems and delivering business improvement. We provide regular public training courses in locations around the UK, and our Virtual Training classroom is available globally. Bywater's consultancy services are client orientated and tailored to meet your business requirements with our expert consultants able to provide as much or as little assistance as you need. Our goal is to help organisations run more effective management systems, improve the quality of their products and services, and support them in achieving their own goals. We provide consultancy across an extensive range of standards including ISO 9001, ISO 45001, ISO 27001 and ISO 17025. Our experienced ISO consultants can assist you in achieving, maintaining and continuously improving your management system, from undertaking a gap analysis to designing and implementing your management system to pre-assessment auditing. The Bywater team is committed to delivering the highest quality of service, from initial contact through booking to the interactive classroom experience. We monitor feedback and analyse our performance rigorously, with the aim of continually improving our service.
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About iso 13485 providers in united kingdom.
CertBetter lists verified ISO 13485 Medical Devices Quality Management providers based in or serving United Kingdom. Filter by service type (consultant, certification body, training), compare profiles and verified reviews, and submit a single free quote request to hear from multiple specialists simultaneously.
Not necessarily. Many ISO 13485 Medical Devices Quality Management consultants work remotely with clients worldwide and can deliver gap analysis, documentation, and training entirely online. However, a locally based consultant in United Kingdom may have an advantage for on-site work, regulatory familiarity, and surveillance audit support.
Total ISO 13485 Medical Devices Quality Management certification costs in United Kingdom typically range from $5,000 for a micro business to $60,000+ for a complex medium-sized organisation. This covers consultant fees (gap analysis, implementation, documentation, training) plus certification body audit fees (Stage 1 and Stage 2). Getting multiple quotes through CertBetter is the fastest way to benchmark pricing.
Most United Kingdom businesses complete first-time ISO 13485 Medical Devices Quality Management certification within 4–12 months. Organisations with existing documented processes and a dedicated internal lead move significantly faster — sometimes within 3 months. A gap analysis at the start is the best way to set a realistic and accurate timeline.
A ISO 13485 Medical Devices Quality Management consultant helps you prepare — conducting gap analysis, building documentation, training staff, and getting audit-ready. A certification body (CB) is an accredited organisation that independently audits your management system and issues the certificate. They are separate roles, and you typically work with both. CertBetter lists both types in United Kingdom.
Technically yes, but it is significantly harder and slower without expert guidance — especially for first-time certification. Most United Kingdom businesses that attempt self-certification take longer, face more audit non-conformances, and end up spending more overall. A consultant typically pays for themselves in time savings and reduced re-audit risk.