It’s a strategic decision that helps you manage timelines, costs, and compliance more effectively, while offering tangible benefits:
- Audited and proven processes
- Structured, reliable project planning
- Teams aligned around a shared focus on quality
- Robust documentation to support regulatory submission
What is an ISO 13485-Certified Company?
ISO 13485 is an international standard that defines the requirements for a quality management system (QMS) specific to the medical device industry. To obtain and maintain this certification, a product development company must demonstrate that it applies rigorous, structured processes at every stage of development. These processes are regularly audited by independent third parties to ensure ongoing compliance with the standard.
ISO 13485 Benefits vs. Non-Certified Firms
| With ISO 13485-certified firm | Without ISO 13485 | |
|---|---|---|
| Regulatory Strategy | Regulatory strategy defined from the start of the design phase. Design and documentation aligned with standards recognized by the FDA, Health Canada, and the MDR*. Faster approval and market access. | Risk of misalignment with regulatory expectations. Risk of delays due to non-compliance. Undefined regulatory strategy. |
| Documentation Best Practices & Document Control | Seamless integration into the QMS facilitates the creation of the Medical Device File (as defined by QMSR), also known as the Design History File (DHF), and the Device Master Record (DMR). | Need to revise or gather documentation late in the process. Documentation may be missing or not properly referenced. |
| Design Controls | Definition of design inputs/outputs and requirements, design verification and validation (V&V), and design change control. | Lack of defined requirements, potentially resulting in an unsatisfactory design. |
| Risk Management | Integrated risk management process compliant with ISO 14971:2019. | Limited or informal risk analysis. |
| Traceability | Full traceability throughout the product lifecycle to ensure safe and effective design. | Lack of planning and traceability. Inconsistent documentation. |
| Usability Engineering | Early integration of human factors according to IEC 62366-1. User-centered design. High market acceptance. | Usability overlooked or not compliant with the standard. Risk of non-compliance, leading to added costs and delays. Unidentified user needs, resulting in a product that doesn’t meet them. Low market acceptance. |
| Supplier Qualification | Suppliers selected and approved based on defined quality criteria. Controlled purchasing process that ensures quality components meet approved specifications. | Risk of non-conforming components from unreliable suppliers that cannot be used in production. |
| Development Efficiency | Fewer late-stage changes and smoother regulatory submissions. | More last-minute changes and submission delays. |
| Client & Stakeholder Trust | Recognized signal of maturity and rigor in the development process. | May be perceived as less reassuring. |
| Post-Market Surveillance | Integrated processes for complaint handling and continuous improvement. Corrective and preventive action (CAPA) processes in place. | No or overly complex tracking of issues and CAPA processes. |
| Audit Readiness | Documentation already structured and audit-ready. | Unstructured documentation requiring significant effort to retrieve. Increased risk of non-compliance. |
*Deviations exist, and ISO 13485 compliance does not guarantee full compliance with all applicable regulations.
Audited and Proven Processes
Entrusting the development of your medical device to an ISO 13485-certified company means choosing a partner whose quality management system has been independently audited and validated. Every stage, from project definition to commercialization, including verification and risk management, is governed by regulatory requirements applied consistently and effectively across all projects.
For you, it all comes down to one key element: trust. Trust in estimates grounded in proven methods. Trust in risks addressed early. Trust in a structured framework that leaves nothing to chance.
Structured, Reliable Project Planning
An ISO 13485-certified company follows well-defined procedures to assess the scope, effort, and regulatory implications of a project. This structured approach enables more accurate cost estimates, a realistic timeline, and a clear understanding of the actions required to meet FDA, Health Canada, or European Union requirements.
Unlike rough estimates or siloed analyses by individual disciplines, a certified quality management system supports cross-functional planning. This ensures smarter resource allocation, active risk identification by all teams, and fewer unexpected changes during development.
Teams Aligned Around a Shared Focus on Quality
Applying ISO 13485 is not just about documenting processes, it’s about making sure they are integrated and understood by everyone through clear, targeted training. This ensures that all teams follow a shared framework, reinforcing both consistency in work practices and individual accountability.
The benefits go far beyond compliance. This approach strengthens cross-functional collaboration, reduces misunderstandings, and helps projects run more smoothly. From start to finish, everyone speaks the same language, supporting transparent and informed decision-making.
Regulatory Submission-Ready Documentation
Entrusting your medical device development to an ISO 13485–certified company signals to regulatory authorities that activities have been conducted in line with recognized standards from the earliest stages of the project.
This structured approach ensures robust documentation throughout the development process. So when it’s time to submit, your technical file is complete and you’re not held back by missing information.
Main standards and regulations guiding medical device development
| Standard | Description |
|---|---|
| ISO 13485 | Medical devices — Quality management systems |
| ISO 14971 | Medical devices — Application of risk management to medical devices |
| IEC 62366-1 | Application of usability engineering to medical devices |
| SOR/98-282 | Medical Devices Regulations (Health Canada) |
| FDA 21 CFR Part 820 | FDA’s Quality System Regulation (QSR)* |
| IEC 62304 | Medical device software — Software life cycle processes |
| IEC 60601-1 | Medical electrical equipment — General requirements for basic safety and essential performance |
*In February 2026, the FDA will replace the Quality System Regulation (QSR) with the Quality Management System Regulation (QMSR), aligning its requirements with ISO 13485.
Choosing an ISO 13485–certified company means partnering with a team you can trust to bring your medical device to market with confidence.
At CLEIO, our ISO 13485 certification and robust quality management system ensure we approach every project with precision and consistency. Our goal? To deliver a safe, reliable, high-performance medical device that meets regulatory requirements and industry expectations.
