ISO 13485
Medical Device Quality Pathway
ISO 13485
ISO 13485 is the internationally accepted standard for quality management in the medical device industry. iB49, simplifies the confusing rules and regulations for manufacturers and suppliers. We set up solid, reliable procedures that make sure your products are safe, easy to track, and legally cleared to be sold anywhere. product safety, traceability, and market access.
Who needs ISO 13485?
Medical device manufacturers, subcontractors, distributors, and service providers involved in device lifecycle management.
Key benefits
In essence, ISO 13485 is the essential quality foundation that ensures your medical devices are consistently safe, legally compliant, and ready for global commercial success.
Compliance
Ready for global market access (EU, UK) and regulatory approvals.
Safety
Ensures product integrity and device safety using robust processes.
Efficiency
Faster approvals and fewer costly errors or production nonconformities.
Traceability
Full visibility for tracking parts; simplifies risk management and recalls.
Our Approach
Our structured four-step methodology ensures your organization achieves ISO 13485 compliance efficiently and sustainably.
ASSESS
Conduct a detailed Gap Analysis project to benchmark your current systems and practices against all specific ISO 9001 requirements, defining the project scope.
STRATEGIZE
Develop a Tailored QMS Roadmap, complete with key performance indicators (KPIs) and a comprehensive documentation plan.
EXECUTE
Deploy new Standard Operating Procedures (SOPs), provide staff training, and establish robust internal controls and record-keeping.
SUCCEED
Manage the final Certification Process, including pre-audits, corrective action closure, and complete support through the final audit.
Final Documentation and Tools
Technical documentation checklist, device history file templates, risk management records, validation plans, certification support.
F.A.Q.
Global Market Access and enhanced Risk Management. The certification is the international benchmark for quality and safety, allowing you to access new international markets while implementing a robust system to continuously identify and mitigate risks throughout the device lifecycle.
No, but it is a prerequisite for regulatory compliance and market access in regions like the EU (MDR), Canada, and Australia. The standard is the globally recognized foundation for a compliant Medical Device QMS.
Typically 6 to 12 months for initial setup, implementation, and the final Stage 2 certification audit. This timeline varies based on your organization’s size, product complexity, and existing Quality Management System (QMS) maturity.
No, ISO 13485 does not replace regulatory approvals but provides the essential, internationally recognized Quality Management System (QMS) compliance foundation needed to support submissions like CE Mark or UKCA marking.
Yes, certification is achievable for startups with targeted project scoping and efficient utilization of internal resources or expert consultation. Focusing on the core requirements relevant to your immediate scope is key to a faster implementation.