Global Medical Device Quality Consultancy
Your partner for Compliance Excellence Worldwide
Who We Are
Founded by Alastair, a seasoned expert with over 25 years of experience in medical device development, successful ISO 13485 and MDSAP quality systems implementation, and program management. MEDxQuality offers deep industry insight and hands-on support.
In addition to core compliance services, MEDxQuality Services provides independent board advisory support and conducts compliance due diligence audits to support fundraising efforts across all series stages.
Backed by a global network of trusted consultants and specialists, MEDxQuality Services delivers tailored, end-to-end solutions to meet your regulatory, strategic, and operational needs—wherever you are in your journey.
1) Quality Systems That Work for Your Business
Struggling with a Quality Management System (QMS) that slows you down instead of supporting your growth? We design and implement QMS solutions that align with your products, people, and company culture—ensuring real value and high adoption.
- ISO 13485:2016 Implementation
End-to-end QMS development tailored to your organisation—scalable, practical, and fully aligned with your business needs to enhance adoption and conformity
- eQMS Implementation & Validation
Digital quality systems configured and validated for compliance, usability, and long-term success.
- Process Optimisation & Troubleshooting
Targeted assessments to identify inefficiencies, improve adoption, and boost overall system performance.
- Audit Readiness & Remediation
Expert review and action plans to prepare for audits or correct issues after regulatory findings, including mock MDSAP & FDA audits
2) Comprehensive Product Development & Compliance Support
Is your product development process hindering your growth or lacking the structure needed to drive your business forward?
Many businesses face the challenge of products failing late in development or once on the market—whether due to overlooked risks, inefficiencies in the process, or regulatory hurdles. We can help you identify and address these issues early, optimising your development pipeline and reducing the likelihood of costly failures later on.
- Product Development Process Assessment
Streamlining and efficiency evaluations to enhance your development process and ensure optimal outcomes while maintaining compliance with Design Controls
- FDA Q-Sub, 510(k) & Technical File Authoring & Support
Expert authoring and administration of FDA Q-Subs, 510(k) filings, and technical documentation to ensure timely and compliant submissions.
- Risk Management
Implementation and integration of robust risk management processes compliant with ISO14971 to mitigate potential risks throughout the product lifecycle.
- eTool Assessment & Implementation
In-depth assessment and tailored recommendations for eDMS, Requirements Management, Risk Management, and Regulatory Compliance Systems, with full implementation support when required.
3) Board Advisory & Investor Due Diligence
Considering an investment in a medical device start-up but unsure what to look for or what questions to ask?
MEDxQuality Services offers expert board advisory and comprehensive investor due diligence audits to support your fundraising efforts—from seed through Series C and beyond. We help investors and stakeholders assess technical feasibility, regulatory readiness, quality system maturity, and overall risk, ensuring informed decisions and greater confidence in your investment.