Medical Device Design
Wideblue is a trusted partner in medical device design and development, supporting innovators from initial feasibility concept through design to regulatory approval and full-scale manufacture. With ISO 13485:2016 accreditation for both design and manufacture, we provide the technical rigour, regulatory insight, and programme management required to bring complex medical technologies to market with confidence.
Our multidisciplinary engineering team combines deep technical expertise with proven experience navigating stringent medical regulations. We understand the challenges of developing compliant, reliable medical devices and are committed to delivering robust, high-quality solutions at every stage of the product lifecycle, without compromising innovation or speed to market.
Regulatory-Led Development and Risk Management
In medical device development, effective risk management and comprehensive documentation are as critical as the engineering itself. At Wideblue, we work collaboratively with our clients to create and maintain the full documentation package required to support the technical file and submission to the notification body.
Generally, there are two approaches:
1. Established QMS in place
If you already operate under an ISO 13485-compliant Quality Management System, we integrate seamlessly with your processes and templates, ensuring documentation remains current and aligned as development progresses.
2. QMS not yet established
If you do not yet have an ISO 13485-accredited QMS, we can develop all required documentation under our own certified system and transfer the complete, audit-ready package to you at project completion.
Whichever route you take, our team brings extensive experience across all stages of medical device development, ensuring regulatory confidence and technical integrity throughout.
Small-Scale and Volume Manufacturing
Wideblue offers in-house small production runs, under our ISO 13485:2016 accreditation, ideal for pilot builds, verification activities, and devices intended for clinical studies.
For larger-scale production, our parent company, Pivot International, provides access to two ISO 13485:2016-certified manufacturing facilities capable of supporting volume production, enabling a smooth transition from prototype to commercial manufacture.
Our medical device expertise includes:
- Product Requirement Specifications
- Human Factors
- Risk Management and Compliance Documentation
- Product Design for Standards Including ISO 60601-1 and IEC 62304
- Regulatory Strategy and Submissions Support
- Full Technical Design History Documentation
- Prototype through Full-scale Medical Device Manufacture under ISO 13485:2016
With Wideblue, you gain a credible, innovation-focused partner dedicated to turning medical technology concepts into compliant, manufacturable, and market-ready products.
To see some of our designs in our medtech portfolio, click here. To speak to a member of our team, click here.