Chris Hands

Founder & Principal Consultant @Hands On Research Limited

GB

Hands-On Research was born out of a gap I saw time and time again: medical device companies struggling to keep up with evolving regulatory demands—especially around Clinical Evaluation and EU MDR submissions. After years in the industry and seeing projects stall under the weight of unclear expectations and fragmented documentation, I decided it was time to offer something more direct, more collaborative, and much more practical. Our mission is simple: to give MedTech companies access to clean, compliant, submission-ready documents - without jargon, confusion, or delay. What started as a clinical writing consultancy has grown into a full-service regulatory partner. I’ve built a strong, vetted team around me - specialists in Quality Assurance, Regulatory Affairs, Risk Management, and Post-Market Surveillance - so we can offer end-to-end support across the entire product lifecycle. We’re “hands-on” by name and by nature. Whether it’s drafting CERs, implementing a QMS, or responding to Notified Body feedback, we work alongside our clients - not above them. Core Highlights Delivered 100+ CERs across Class devices Helped startups and SMEs navigate EU MDR and UKCA submissions Built scalable clinical evaluation frameworks for international device manufacturers Advised on complex risk and PMS systems across implantable, diagnostics, and software-based devices Supported QMS development and auditing aligned with ISO 13485 and ISO 14971 Led client workshops and team training to internalize compliance processes

London School of Hygiene and Tropical Medicine, U. of London

MSc, Medical Parasitology