QReg, proudly based in the UK, is at the forefront of medical device regulatory consultancy, combining expertise with innovation to navigate global compliance challenges.
Our team makes MDR 2017/745, CE marking, UKCA accreditation, FDA approval, ISO13485 and MDSAP accreditations.
We offer Customised, proactive consultation that enables your company to achieve full compliance for safe and effective medical devices to be placed on the market.
Partner with QReg for a journey marked by clarity and confidence. Foster healthcare innovation by embracing simplified compliance for your medical devices.
We want you to try our services, that is why we are offering Free 5 Hours of consultancy worth £900 at No Cost To You.
All you have to do is provide your contact details and our team will get in touch.
Upon understanding your requirements, we will promptly proceed to deliver the requested services, ensuring a straightforward and transparent process without any sales pitches. In exchange, we kindly request an honest review upon the completion of our work.
Offer is for only first 10 companies, and will be served on a first come first serve basis.
In a world where consultancy often feels distant and detached, we at QReg redefine the experience.
Imagine a consultancy that doesn’t just work for you, but with you, becoming an integral part of your team. Our approach is not just about ticking boxes and completing tasks; it’s about building and maintaining meaningful relationships.
At QReg, we’ve partnered with industry leaders like GCE Healthcare and Therapy Equipment Ltd, among others, to simplify and support their process. We don’t just communicate via emails and calls.
We believe in the power of on-site visits, getting to know each member of your team personally.
This allows us to identify the right person for specific tasks, ensuring efficiency and precision in our collaborative efforts.
Our holistic approach sets us apart. We delve into areas beyond the typical consultancy scope, like “enhancing team dynamics, optimising internal processes, or providing innovative market insights. It’s not just about meeting standards, it’s about exceeding them, together!
Welcome to WReg, where quality is our commitment. We are proud to announce that we are ISO 9001 certified, ensuring our dedication to consistently delivering products/services that meet the highest standards of quality and customer satisfaction.
QReg excels in MDR 2017/745 transitioning, CE marking, UKCA accreditation, FDA approval, ISO13485 and MDSAP accreditations, pre-market approvals, post-market surveillance, mock audits, and supporting notified body audits. For those seeking an in-house solution, we offer dedicated contractors who integrate seamlessly with your team, backed by our full consultancy’s expertise, resources, and QARA network, ensuring comprehensive support and partnership without additional costs.
QReg specialises in guiding medical device manufacturers through the rigorous process of regulatory compliance, ensuring products meet the highest standards for safety and efficacy.
Our services encompass a broad spectrum, from MDR transitioning, CE marking, FDA registration to UKCA marking and bespoke integration and remediation activities. We excel in navigating the complexities of global regulatory requirements, offering tailored solutions for product classification, technical documentation, labelling and IFU, risk management, biocompatibility evaluation, clinical evaluation, and post-market surveillance ensuring devices continue to meet regulatory standards after launch.
For international manufacturers, our UK Responsible Person (UKRP) service facilitates compliance and market access in the UK, acting as your local regulatory liaison. With QReg, you gain not just a service provider but a dedicated partner in achieving and maintaining regulatory compliance for your medical innovations.
Quality Assurance (QA) in the medical device industry is pivotal for ensuring products are safe, effective, and meet rigorous regulatory standards.
QReg offers QA services that cover the product lifecycle, from design to manufacturing and post-market surveillance.
Our expertise includes implementing quality management systems compliant with ISO13485, MDSAP, conducting internal and supplier audits, and preparing for external audits by regulatory bodies.
Our approach at QReg emphasises risk management, process validation and continuous improvement to meet customer and regulatory requirements.
Our goal is to help clients implement and maintain an accredited effective quality management system ensuring product quality and safety.
QReg expertly navigates medical device companies through the nuanced design control process, crucial for aligning product development with regulatory standards and user needs.
This meticulous journey from concept to commercialisation involves strategic planning of design inputs, rigorous design reviews, comprehensive verification and validation, and diligent maintenance of design history files.
Such precision ensures devices not only meet the highest safety, effectiveness and quality benchmarks but also achieve regulatory compliance seamlessly, paving the way for market success.
Validation planning is a critical phase in the development of medical devices, ensuring that all products are rigorously tested and proven to perform as intended before reaching the market.
QReg excels in crafting comprehensive validation plans that encompass every aspect of product testing — from design validation to production validation and ongoing product monitoring.
This strategic approach guarantees that devices not only comply with stringent regulatory standards but also meet the highest levels of safety and efficacy, ultimately facilitating smoother regulatory approvals and enhancing patient care.
Contract recruitment consultancy involves offering specialised services to companies looking for flexible staffing solutions, providing skilled professionals for temporary, contract-to-hire, or project-based positions, especially in sectors where expertise and quick adaptation are key.
This approach allows businesses to address immediate resource needs without the long-term commitment of hiring permanent staff, facilitating agility and efficiency in project execution and operational management.
At QReg we offer dedicated contractors who integrate seamlessly with your team, backed by our own consultancy’s expertise and resources ensuring comprehensive support and partnership without any additional costs.
This service approach eliminates the uncertainty when selecting a stand-alone contractor, as our contractors are backed by our proficient and cohesive team.
A key aspect of our consultancy’s strength is our broad network, including an expert panel with extensive knowledge and experience, spanning connections with MHRA, notified bodies, and competent authorities. This network complements our in-depth expertise, enhancing the comprehensive support we offer to our clients so they can navigate the regulatory and quality field with confidence and efficiency.
Quality Assurance Specialist: Focuses on ensuring medical devices meet strict quality standards and compliance requirements through rigorous testing and process evaluations, guaranteeing safety and efficacy.
Regulatory Affairs Specialist: An expert at navigating complex regulations, they guarantee compliance with both local and international regulations concerning medical devices. This paves the way for successful market entries and approvals.
Audit Specialists: Specialise in conducting thorough audits to assess compliance with regulatory standards, quality management systems, and industry best practices, identifying areas for improvement.
QARA Associates: Supporting quality assurance and regulatory affairs actions helps connect product development with regulatory compliance, guaranteeing that products adhere to quality standards and regulatory demands.
Our team brings 10-20 years of experience in regulatory compliance and quality assurance in the medical device sector, guaranteeing deep understanding and knowledge.
We have connections to an expert panel, including contacts from MHRA, notified bodies, and competent authorities, enriching our consultancy with a broad range of insights and expertise.
Whether you need a Quality Assurance Specialist, a Regulatory Affairs Specialist, Audit Specialists, or QARA Associates, we tailor our services to meet your specific needs, preparing your medical devices to not only comply with regulatory standards but also exceed market expectations.
A collaborative team effort exceeds the constraints of individual hires, where continuous progress is maintained despite unforeseen circumstances such as sick leave.
Our extensive experience with leading manufacturers gives us exceptional insights, enabling us to effectively manoeuvre through complex regulatory environments.
We deliver services on par with, or surpassing, top consultancies at a more accessible price point, offering exceptional value without compromising on quality.
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