ISO 13485 Medical Devices
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Gaining ISO 13485
ISO 13485:2016 sets the standard for Medical Devices
Is your business keen to ensure the devices in your medical laboratory are safe, effective, and delivered to a high standard?
As a medical device manufacturer, ISO 13485:2016 is the most accepted global standard of its kind. If your business wants to put competency at the forefront of your operations, Compliant can talk you through how this certification will improve and validate the way you work.
Increase Employee Engagement
Increase Your Sales
Reduce Your Costs
Ensure Customer Retention
Our Dedicated Process and Post Certification Options
Research & Analysis
- We customise the standard in a way that works for your business.
- We assist you in putting your documented management system in place
- Then make sure it’s compliant with your chosen standard(s)
- We will carry out a document review first to check that you have a system
- Then we will carry out onsite assessments to check that you do what you say your system does
- We will provide you with an opportunity to resolve any findings via our detailed report
- Once these have been rectified, certificates are issued and registration to applicable schemes are completed
Trusted by Top Companies Across the UK
Having a reliable ISO consultant that you trust is essential in making the process as straightforward as possible.
Compliant customise the standard in a way that works for your business. We support both SMEs and Large Corporates. Compliant delivers UKAS ISO 13485:2016 certification.
Don’t Just Take Our Word For It
“Compliant FM delivered carried out a superb job on our management system and helping achieving certification to UKAS ISO 9001 and the NHSS 16 highways sector scheme – thanks”
WHY INVEST IN ISO 13485
Make Your Own Opportunities
Getting UKAS ISO 13485:2016 certified displays your commitment to ensuring that medical devices used in healthcare settings are designed, produced, installed, and serviced to the highest standards.
The standard is suitable for businesses of all sizes and can help enhance productivity and improve the reputation of your business.
Pricing Models For Every Need
Compliant understand that our clients are involved in running their companies on a day to day basis. The need to retain finance within the business is paramount.
Compliant can spread the costs of implementation across the 24-month life cycle of the certification from as little as £68.75 plus VAT per month.
We can establish the exact timeline and scope for all the standards with a comprehensive Gap Analysis from £199 plus VAT.
Check out our full range of certifications!
- Ongoing Support
Other Accreditations We Can Help With
- This standard provides the framework for an effective Information Security Management System (ISM
- Protects corporate information and data being accessed, corrupted lost or stolen
- The International Standard for Quality Management Systems
- Helps organisations ensure that they meet the needs of customers and other stakeholders
- Enhances productivity and improves the reputation of your business
- ISO 45001 is the world’s international standard for occupational health and safety
- Protects employees and visitors from work-related accidents and diseases