Formally Hands On Research
ABOUT US
We help manufacturers prepare clear, practical and audit-ready documentation for UK, EU, US and wider regulatory review. Our support covers clinical evaluation, PMS, PMCF, risk management, biocompatibility, usability, sterilisation, technical documentation and regulatory strategy.
We work closely with your team to identify gaps, strengthen evidence and make the route to submission clearer. Our clinical, regulatory, scientific and medical writing specialists bring practical experience across a range of device types and risk classes, helping you to build documentation that is easier to review and better connected to patient safety.
Hands On MedTech was formerly known as Hands on Research. We changed our name because the business has grown, and our new identity better reflects the specialist medical device regulatory work we now deliver.
REGULATORY CONSULTANCY
Our regulatory consultancy support is tailored to the device, the organisation and the stage of the project.
We can help with a new submission, a technical file review, clinical evidence planning, notified body feedback, PMS, PMCF or wider regulatory strategy. We work closely with regulatory, quality and clinical teams, providing focused support where it is needed most.
Our advice is practical, proportionate and grounded in the realities of medical device compliance. We do not make the process more complicated than it needs to be. We help you make sense of the requirements, prepare stronger documentation and approach regulatory review with greater confidence.
If you are preparing for submission, responding to regulatory feedback, or reviewing the strength of your clinical and technical documentation, contact Hands On MedTech to discuss how we can help.
WHY CHOOSE US
EXPERTISE
We have extensive knowledge and experience in regulatory affairs, clinical evaluation, biocompatibility testing, post-market surveillance, and other areas of medical device consulting. We stay up-to-date with the latest regulations and guidance, and we use our expertise to help our clients navigate complex regulatory requirements and achieve their goals.
QUALITY
We are committed to providing high-quality, reliable services that meet the needs of our clients. We have a rigorous quality management system in place that ensures that our work is accurate, thorough, and compliant with relevant regulations and standards.
CUSTOMISED SOLUTIONS
We understand that every client and every device is unique, which is why we offer customised solutions that are tailored to the specific needs of each client. We work closely with our clients to understand their goals, challenges, and constraints, and we develop solutions that meet their needs and exceed their expectations.
COST EFFECTIVE
We offer competitive pricing and cost-effective solutions that help our clients achieve their goals while staying within their budgets. We are committed to providing value to our clients and helping them achieve their goals in the most efficient and cost-effective way possible.
PARTNERSHIP
We believe in building long-term partnerships with our clients based on trust, collaboration, and mutual respect. We are committed to working closely with our clients to achieve their goals and help them succeed in the competitive medical device market.