Formally Hands On Research
REGULATORY COMPLIANCE
Hands On MedTech supports medical device with regulatory strategy, technical documentation and regulatory writing across both pre-market and post-market activities.
Our consultants can support specific areas of a project or manage the work from initial planning through to submission. This includes preparing, reviewing and updating technical documentation, supporting submissions to Notified and Approved Bodies, and helping manufacturers meet the requirements for CE marking, UKCA marking, FDA 510(k) clearance, PMA approval and registrations in other global markets.
We match each project with consultants who have the right technical and regulatory experience for the device, market and stage of development. This helps us provide focused support, work efficiently and produce documentation that is clear, consistent and suitable for regulatory review.
A clear regulatory strategy provides the foundation for bringing a medical device or in vitro diagnostic to market. It defines the intended pathway, confirms the device classification and identifies the regulatory requirements that apply in each target market.
Where appropriate, we also carry out a regulatory gap assessment. This compares your current documentation and compliance position against the relevant market requirements and identifies any gaps that need to be addressed. The assessment may cover technical documentation, clinical evidence, quality management systems, submission requirements, Notified Body expectations and key project timelines.
The result is a practical regulatory plan that helps your team understand what is required, prioritise the next steps and reduce the risk of avoidable delays.
What we offer
Regulatory Strategy
We define the most appropriate regulatory pathway for your device, including classification, target markets, applicable standards, evidence requirements, and submission timelines.
Global Submissions and Market Access
We support CE marking, UKCA marking, FDA 510(k) clearance, PMA applications and registrations in other international markets. This may include submission planning, document preparation, responding to regulatory questions and coordinating with Notified Bodies, Approved Bodies and regulatory authorities.
Our support can cover a single workstream or the management of a wider regulatory programme, depending on your internal resources and project needs.
Regulatory Gap Assessments
We review your current documentation and compliance position against the relevant regulatory requirements. This identifies missing information, areas requiring improvement, and the actions needed to prepare for submission or review.
Technical Documentation
Our consultants prepare, review and update technical documentation, ensuring that information is clear, consistent, and aligned across areas such as clinical evidence, risk management, labelling, post-market surveillance and device claims.
A Clear Regulatory Path, Built Around Your Device
Regulatory projects are easier to manage when the pathway is clear from the outset. The right strategy helps your team understand what is required, where the main gaps are and which actions should take priority.
At Hands On MedTech, we provide practical support that is shaped around your device, target markets and stage of development. Whether you need help defining a regulatory strategy, preparing technical documentation, responding to regulatory feedback or managing a wider submission programme, our consultants bring the experience needed to keep the work focused and moving forward.
We work as an extension of your team, providing the level of support you need without adding unnecessary complexity. Our aim is to help you make informed decisions, prepare stronger documentation and reduce the risk of avoidable delays.
To discuss your regulatory plans and the support your project may need, contact our team for an initial conversation.