If you’re a medical device manufacturer, passing ISO 13485 and CE Marking audits is a critical milestone. These audits are not just about compliance – they’re about demonstrating that your products are safe, effective and ready for market. Let’s walk through what to expect from these audits, how they’re connected and tips to prepare.
ISO 13485 and CE Marking: How They Work Together
ISO 13485 is the international standard for quality management systems (QMS) in the medical device industry. It’s the foundation of a medical device business; ensuring you deliver consistent, high-quality products that meet regulatory requirements throughout the product’s lifecycle. CE Marking is the entry to selling medical devices in Europe, under the EU Medical Device Regulation (MDR) 2017/745. The EU MDR ensures your product meets strict safety and performance standards.
Here’s where the two link:
• ISO 13485 is your backbone for MDR compliance: To meet CE Marking requirements, your QMS needs to align with ISO 13485.
• Risk management: Both emphasise the need to identify, mitigate and manage risks throughout the product lifecycle.
• Post-market surveillance and traceability: Both require systems for tracking product performance and addressing any issues once the device is on the market.
ISO 13485: An overview
An ISO 13485 audit evaluates how effectively your QMS supports the safe design, production and delivery of medical devices.
An ISO 13485 audit is usually in 2 stages:
What happens after the audit?
Some tips to ensure you’re ready:
- Build a Solid QMS
• Make sure your QMS is clear, structured and user-friendly.
• Auditors will check if it aligns with ISO 13485 requirements and supports regulatory compliance.
• Ensure the QMS is woven throughout the business and processes. - Risk Management
• ISO 13485 requires a risk-based approach in line with ISO 14971.
• Be prepared to show how you identify, assess and control risks at every stage.
• Risk Management needs to be considered throughout the entire product life cycle: from design to post-market. - Design and Development Processes
• Auditors expect to see traceability from user needs, design inputs, design outputs through to validation.
• Keep detailed records of design reviews, design changes and approvals.
• Design and Development Procedures, Validation Procedures, and Change Management can help with this. - Supplier Management
• Have a clear system for selecting, evaluating and monitoring suppliers.
• Maintain audit records and evidence of ongoing supplier reviews.
• Risk Assess your suppliers. - Training
• Ensure that all team members are trained appropriately for their roles and responsibilities.
• Maintain a training matrix and records of competency assessments.
Preparing for Both Audits
Preparation for these audits is essential and will allow you to approach them with confidence. Here are some things to keep in mind:
ISO 13485 and CE Marking audits might seem daunting, but with the right preparation and knowledge, you will be able to sail through the calm audit waters.
How can LFH Help?
• Technical Documentation
• Risk Management
• Clinical Evaluation
• Useability
• Biological Evaluation
• Intended Use Support
• Ongoing Consultancy Support
• QMS Implementation
• Audit Support
• Notified Body Support
•Regulatory Intelligence
We can make regulations easy for you. Good luck!
Need further help?
If you have any questions please get in touch with our expert consultants today, by phone on +441484662575 or via email at info@lfhregulatory.co.uk.
