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ISO 13485: Medical Devices
At each stage of your product’s life, regulatory requirements are scrutinised in the manufacture, delivery, or service stages. Laboratories and other organisations in your industry are expected to exemplify a sound Quality Management System (QMS) to demonstrate best practices.
Are you keen to ensure the devices in your medical laboratory are safe, effective, and delivered to a high standard? Do you want to be brought up to speed with national and global requirements for your industry? As a medical device manufacturer, the ISO 13485 standard is the most accepted global standard of its kind. If your business wants to put competency at the forefront of your operations, IMSM can talk you through how this certification will improve and validate how you work.
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What is ISO 13485?
Certification ensures that medical devices in healthcare settings are designed, produced, installed, and serviced to the highest standards. ISO 13485 originates from the need to meet client obligations and the regulatory and legal specifications for business owners involved in the manufacture of medical devices manufacturers.
Adopting the ISO 13485 standard into the heart of your practices means you will build a clear, practical foundation to address these specifications by taking control of your supply chain with a robust framework that will reduce costs. Your business will also demonstrate a commitment to safety, quality, and competence for medical device manufacturing, recognised worldwide.
Throughout the ISO 13485 certification process, you will be guided by a dedicated ISO consultant. They will start by assessing your business and then help you to use the results to improve your medical device manufacturing quality management system. We work with the senior management team to ensure the ISO 13485 standard framework is embedded throughout your organisation before you are assessed by a third-party auditor who awards the certification.
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The Benefits of ISO 13485
1. Taking control of your supply chain
4. Up-to-speed with Requirements
2. Robust Control Processes
5. International Recognition
3. Reducing Costs
Steps to getting
ISO 13485 certified
Woking towards ISO 13485 certification with IMSM is a trouble-free, step-by-step approach.
1. Initial consultation
We help you outline your goals, focusing on what your business wants to achieve and how it defines success, particularly in relation to your client’s requirements. You and your ISO consultants will agree on reasonable outcomes and delivery dates.
2. System Documentation
Our client portal IMSMLoop offers a comprehensive insight into the progress of your ISO implementation, along with copies of the relevant audit reports, certifications, and any necessary corrective actions. The portal serves as a central hub for tracking your ISO journey.
3. ISO 13485 Framework Adoption
Ensuring the framework is embedded throughout your organisation, we can also develop and deliver tailored training for staff to ensure that the understanding and implementation of ISO 13485 is watertight. Creating consistency across your organisation.
4. Submission to External Auditor
Your organisation applies to the third-party certifying body that you have selected to conduct your audit. This audit objectively determines whether your business conforms to ISO 13485, and the relevant accompanying documentation is accessible through our client portal, IMSMLoop.
Why choose IMSM?
Simple: We make it simple. Since 1994, we've helped businesses achieve ISO certification, with over 150 experts worldwide and 15,000+ clients trusting us to implement their ISOs. We've proven to be experts at handling the logistical heavy lifting, saving your company valuable time.
With a transparent fixed fee, flexible approach, and real-time access to updates, documentation, and an array of other features through IMSMLoop, we collaborate with your organisation to make any ISO implementation as straightforward and beneficial as possible.
- World-class gap analysis
- Experienced ISO consultants
- Regular updates
- Flexible terms and contract
- Fixed fee
- Full implementation

Experienced ISO Consultants
How can ISO Specialists help your business?
Getting started with ISO certification might seem daunting; this is often the reason why businesses enlist the help of an ISO consultant. For 30 years, we've supported and guided organisations like yours through certification. Our experienced consultants take the lead on auditing your business, helping you use the results to enhance your quality management system. If necessary, there is also plenty of room for training.
ISO 13485: Frequently Asked Questions
Is ISO 13485 certification mandatory?
Who needs ISO 13485 certification?
How to get ISO 13485 certification?
How long does it take to get ISO 13485 certification?
Is ISO 13485 required for CE mark?
This standard contributes to the following Sustainable Development Goals:
High Quality & Prestigious Brands
Advanced services combined with a large experience and fast performance.
“We decided to use IMSM to help and support us through the process. We were fairly new to this as a company and to have a company like IMSM guiding us through the requirements saved us time and gave us the confidence to present to the external auditors, knowing we had everything covered”
"Our ISO certifications help us provide consistent, quality-focused services that our clients have come to depend on and appreciate.”
“We can now demonstrate, via externally internationally recognised accreditation, that Pall-Ex is the number one pallet network for quality. This also allows us extensive yearly external auditing by our certification provider against a measured standard.”
"Our IMSM Assessor put in a lot of time and effort; they did a really good job for us, helping to organise what we had here. We had a lot of the pieces in place, they just weren’t put together, which IMSM helped us to do. We have a system in place now and we continually follow up on everything. “