qreg.co.uk

What It Is

QReg is a UK-based medical device regulatory affairs and quality assurance consulting firm, primarily serving life sciences and medical device companies. Its focus is not SaaS software, but rather helping companies complete registration, market access, audit preparation, and ongoing compliance around regulatory and quality system requirements such as MDR 2017/745, CE marking, UKCA, FDA, ISO13485, and MDSAP.

Core Capabilities

Based on the site content, QReg’s services cover the full medical device lifecycle: regulatory compliance, product classification, technical documentation, labeling and IFUs, risk management, biocompatibility evaluation, clinical evaluation, post-market surveillance, and UK Responsible Person services. On the quality assurance side, it supports ISO13485, MDSAP, internal and supplier audits, and preparation for external regulatory audits. The company also provides design controls, validation planning, and contract-based QARA/regulatory quality consultants who can be embedded into client teams. In addition, the website separately lists digital marketing services for medical devices, including market analysis, SEO, content, social media, PPC, email marketing, and data reporting.

Pricing and Trial

QReg does not disclose standard packages or clear hourly rates, so its pricing appears to be based on customized consulting quotes. One appealing point is the free consultation: the homepage mentions that the first 10 companies can receive 5 hours of free consultation, valued at £900; the About page also mentions a 1-hour free consultation, valued at £200. Companies can use this to assess its expertise before entering a formal engagement.

Pros and Cons

Its strengths are a clear vertical industry focus and coverage of UK, EU, US, and international registration-related requirements. It emphasizes on-site visits, deep collaboration, and embedded consultants, making it suitable for manufacturers that lack an in-house regulatory and quality team. The website also discloses experience with 1,000+ global device registrations, 100+ technical files, 100+ clinical evaluations, and 30+ notified body audits, and states that the company is ISO 9001 certified.

The downside is that it is not an enterprise software platform, so it lacks common SaaS features such as account systems, permissions, APIs, third-party integrations, deployment options, and data security documentation. Pricing transparency is also limited, and detailed customer case studies are relatively sparse.

Who It’s For and Access from China

QReg is better suited for medical device manufacturers planning to enter the UK, European, or US markets, as well as companies needing short-term regulatory and quality experts, audit preparation, technical documentation, and clinical evaluation support. The text does not provide information on accessibility from mainland China, so this remains unknown.