We’ve built robust quality systems into everything we do, ensuring consistent results from that first unique unit all the way up to large production runs. You can expect the same high standards whether you need one intricate part or 20,000 units. And because we know things change, our scalable production adapts right along with you as your designs evolve and your volumes shift, always with that same commitment to delivering high-quality products that hit the mark.
Our Core Capabilities
Our team’s expertise in quality assurance, risk management, and lean methodologies ensures your products deliver exceptional performance and reliability.
Implement and maintain a robust QMS compliant with ISO 13485 and FDA 21 CFR Part 820, ensuring adherence to global medical device standards.
Drive quality throughout the product lifecycle, from rigorous incoming material inspection and supplier qualification to in-process quality assurance, root cause analysis, and final product testing and validation.
Integrate risk management throughout the product lifecycle to continuously enhance product quality and mitigate potential issues.
Expertise in document control, change management, and conducting internal and supporting external audits to ensure full compliance with medical device regulations.
Utilize lean manufacturing principles to drive continuous improvement in yield, reduce cycle times, and optimize costs.
Oversee and document the validation of manufacturing processes, equipment, and software (IQ/OQ/PQ), alongside product design verification and validation, to guarantee consistent and reliable performance.
Our work
Our quality approach
Beyond just checking boxes, our quality assurance team is deeply embedded in every stage of a product’s lifecycle, consistently ensuring safety, effectiveness, and regulatory compliance.
Standardize your foundation
A robust Quality Management System is implemented and maintained, ensuring compliance with standards such as ISO 13485 and FDA 21 CFR Part 820. The team also develops and updates quality documents, including control plans, inspection plans, and quality requirements, all designed to align with your operational needs.
Secure your critical information
Your controlled documents, including SOPs, work instructions, and vital quality records, are managed, guaranteeing accuracy and accessibility. Through version control, the most current and approved documentation is consistently available.
Vet partners for reliability
To ensure quality, we qualify and audit our suppliers. Should you require the use of a specific supplier, we will add them to our Approved Supplier List (ASL) for consistent oversight. We continuously monitor supplier performance and proactively address any nonconformances, protecting the integrity of all materials and processes.
Orchestrate seamless transitions
All changes to processes, equipment, or materials are evaluated and approved, ensuring thorough documentation and validation. Controlled communication of these changes minimizes disruption and maintains product quality.
Evaluate your systems for peak performance
Thorough internal audits are planned and conducted to assess compliance with all QMS requirements, proactively identifying areas for enhancement. Support is also provided for external audits with suppliers, ensuring they consistently adhere to their stated processes.
Address challenges and anticipate future needs
Active participation in comprehensive risk assessments occurs throughout the entire product lifecycle, from design to post-market activities. Robust risk controls are implemented and continuously monitored to ensure product safety and effectiveness.
Safeguard your product lifecycle
Comprehensive risk assessments are actively performed throughout the entire product lifecycle, from design to post-market activities. Robust risk controls are then implemented and continuously monitored to ensure product safety and effectiveness.
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Additional capabilities
Your product’s journey from concept to customer is complex, and we’re here to support you the whole way.
Our assembly expertise ensures that every product is built with an inherent understanding of quality, directly translating design specifications into a meticulously crafted physical reality.
Our product integration focus means we’re considering quality from the earliest design stages, optimizing components and systems to enhance overall performance and reliability before manufacturing even begins.