Helping Medical Device companies scale
Our Services
Here are just some of our areas of expertise. We are supported by a network of associates enabling us to identify the right expert to apply to your challenge.Product Development
- Project Management
- Requirements Definition
- Risk Management
- Verification & Validation
Quality Management Systems (QMS)
- Creation, implementation and certification of an ISO 13485 compliant QMS.
- Broaden scope to include US FDA regulation.
- Audit preparation
Regulatory Compliance
- Determination of intended use and device risk classification
- Identification of applicable regulations and standards
- Documentation
About Us
XIOMED was founded by Alan Finnerty in 2022 to assist medical device companies overcome product development, manufacturing, QA/RA and commercialisation challenges enabling them to scale their business. Based in Cambridge, UK we have been serving clients locally and internationally.
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Let's discuss your MedTech business challenge
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