Supporting medical devices

Medical devices

BLS supports medical device manufacturers with comprehensive compliance and certification services. We assess embedded systems, firmware, and documentation to ensure readiness for CE, UKCA, and FDA standards. Our independent evaluations help mitigate regulatory risks and validate product safety and performance for global market access.

FAQ

Capabilities

Our technical and compliance expertise helps you launch faster, scale smarter, and lead your market.

Compliance support

We assist with CE, UKCA, and FDA certification, helping clients meet regulatory requirements and ensure patient safety. To learn more about our compliance support capabilities click here.

Technical due diligence

BLS assesses embedded systems, firmware, and productreliability to support safe and effective medical device development. To learn more about our technical due diligence capabilities click here.

Key benefits of working with us

Comprehensive Technical Expertise

BLS brings together specialists in software, hardware, embedded systems, and compliance to deliver end-to-end technical assessments. Our multidisciplinary approach ensures no blind spots, giving you confidence in every aspect of your technology stack—from architecture and infrastructure to certification and scalability.

Industry-Specific Insights

With experience across sectors like aerospace, healthcare, energy, and consumer electronics, BLS understands the unique challenges and demands of each industry. Our tailored assessments and strategic guidance help you meet sector-specific standards and accelerate innovation.

Independent and Trusted Partner

BLS operates as a neutral third party, providing objective assessments that support confident decision-making. Our expertise is valued by technical leaders, investors, and compliance teams alike, helping you build trust and credibility across stakeholders.

Credit card mockups

Insights

Electronics Design

Types of prototype: what, when, how and why?

Discover a comprehensive breakdown of prototype types, ranging from low-fidelity paper prototypes to high-fidelity functional prototypes, each serving a crucial role in the iterative process of product development.

Why is compliance not embraced?

Unravel the complexities surrounding compliance reluctance as this blog delves into the reasons why businesses often shy away from embracing regulatory standards and the potential consequences of such avoidance.

A close-up of a soldering iron working on a green circuit board.

Why use the DFX process?

Explore the transformative power of the DFX (Design for X) process in this insightful blog post, uncovering the myriad benefits it offers for enhancing product design, efficiency, and overall success.

Contact us

Our friendly team would love to hear from you.

hello@bluelightningsolutions.co.uk

+44 (0) 1223 858151

Unit 1, Saint Georges Tower, Hatley St George, Sandy SG19 3SH

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