Supporting Medical Device companies to accelerate products to market and scale
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
Due Diligence
Find out how we can help you manage your investment risk.
About
XIOMED was founded in 2022 by Alan Finnerty to support medical device companies overcome product development, manufacturing, QA/RA and commercialisation challenges enabling them to successfully scale their business. Based in Cambridge, UK we serve clients locally and internationally.
Contact
Let's discuss your Medical Device challenge. Call, email or connect with us on LinkedIn to arrange a free consultation.