What is ISO 13485?
ISO 13485 is the internationally recognised Quality Management System (QMS) standard for organisations involved in the design, manufacture, supply, installation, and servicing of medical devices.
Unlike generic quality standards, ISO 13485 is built specifically for regulatory compliance, patient safety, and product traceability. It is widely expected by regulators, notified bodies, and healthcare customers worldwide.
Risk-Based Approach
Product lifecycle risk management
Regulatory Alignment
MHRA, FDA, and EU MDR compliance
Full Traceability
Complete product and process tracking
Benefits of ISO 13485
Essential certification for medical device organisations
Market Access
Essential for CE/UKCA marking and accessing EU, UK, and international markets for medical devices.
Patient Safety
Ensures devices are consistently safe, effective, and manufactured to the highest quality standards.
Regulatory Compliance
Meets MHRA, FDA, EU MDR requirements. Demonstrates due diligence to regulators.
Traceability
Complete product traceability from raw materials through to end user delivery.
Customer Confidence
Build trust with healthcare providers, distributors, and end customers worldwide.
Process Improvement
Reduce waste, improve efficiency, and enhance product quality through systematic processes.
Who Needs ISO 13485?
Essential for all organisations in the medical device supply chain
Manufacturers
Medical device design & production
Distributors
Medical device distribution
Service Providers
Installation & maintenance
Suppliers
Components & raw materials
Certification Process
Our proven path to ISO 13485 certification
Gap Analysis
Assess current systems against ISO 13485 requirements
QMS Development
Develop documentation, procedures, and quality manual
Implementation & Training
Roll out QMS across organisation with staff training
Internal Audit
Verify compliance and identify improvements
Certification Audit
External audit by accredited certification body
Ready for ISO 13485 Certification?
Ensure your medical devices meet international quality standards. Our experts guide you through certification.
How Much Does ISO 13485 Cost?
The cost of ISO 13485 certification varies based on several factors. Some consultants and certifiers adopt charging models based on the project's complexity, company size, and sometimes even the company's turnover.
At Certigence, our pricing is straightforward, calculated by multiplying an agreed day rate by the number of days work. This is based on the work to be done, mitigated by any the company has done already or will be doing internally. This ensures clarity and transparency, giving you a clear understanding of the commitment before the project commences.
We provide a free telephone or Zoom consultation with one of our consultants to find out enough about your organisation to be able to make a formal proposal without charge or obligation. This allows you to research costs for free before making any commitments!
How Can Certigence Consultants Help?
Certigence's extensive consultant network spans the entire UK and has been operating ISO systems expertise combined with industry know-how for over 25 years. This dual proficiency enables them to comprehend your unique needs and translate them into certifier-accepted procedures that genuinely suit your organisation's operations.
Our services encompass full or partial ISO system development and implementation, including GAP analysis and customised internal training to support system functionality. We craft organisation-specific reports tailored to your activities.
Beyond initial implementation, we conduct internal audits, facilitate management review meetings, and offer ongoing maintenance for short, medium, or long terms. Our presence during certification stages, if desired, ensures assessors avoid unnecessary complexity. Furthermore, we offer pre- and post-certification review services to address certifier-raised concerns, reinforcing your ISO system's effectiveness.
Process Overview
Initiation and Assessment Discussion
We engage in a free, no-obligation discussion to understand your existing systems and operations, allowing us to generate a formal proposal.
Work Commencement and Collaborative Development
Upon acceptance, collaborative work commences to create and install systems, involving you and your team to ensure alignment with your needs, your understanding and acceptance of the results and compliance with ISO standards.
Initial Assessment (Stage 1): Ensuring Systems Meet Standard
The certifier reviews that systems cover all relevant parameters correctly. You may choose to have our consultant present during the initial assessment to assist with any questions the certifier may have.
Final Evaluation (Stage 2): Achieving Certification
The consultant ensures internal audit, management review, and training aspects are covered. The certifier conducts the conclusive Stage 2 assessment, verifying operational systems' alignment with Standard requirements. Upon successful completion, you attain Certification.
Why Should You Use a Certigence Consultant?
At Certigence, we match your requirements with suitable consultants based on their industry expertise, proximity, and compatibility. In the event of a consultant's unavailability, a substitute can step in promptly, avoiding project disruptions and re-hiring expenses. Our consultants have often previously worked with certifiers, learning that side of the procedure – facilitating a seamless Certification process.
This commitment reflects in our track record – a 100% first-time certification success rate spanning over 25 years.
Ready to Speak? What Happens Next?
After contacting Certigence, you'll receive an email or a call from the Director or a consultant. Discussions about needs, timelines, reasons, and costs occur. A consultant will directly engage with you to understand your requirements and system alignment. A formal proposal is then presented for your consideration. Charges apply only from that point if you proceed with the proposal.