ISO 13485

Reach International regulatory compliance for medical devices with this standard.

A medical equipment in a room

ISO 13485 – Medical Devices

At each stage of your product’s life, regulatory requirements are scrutinised – be it in the manufacture, delivery, or service stages. Laboratories and other organisations in your industry are expected to exemplify a sound quality management system 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 king. 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 the way you work.

Why IMSM?

Simple: We make it simple. Since 1994, we’ve been helping businesses achieve ISO certification and have over 150 experts worldwide. With 15,000+ clients trusting us to implement their ISOs, we have proven to be experts capable of handling the logistical heavy lifting, saving your company precious time. With a transparent fixed fee, flexible approach, and real-time access to updates, documentation, and an array of other features through IMSMLoop, we work with your organisation to make ISO 13485 implementation as straightforward and beneficial as possible.

We strive to do this with our:

– World-class gap analysis
– Experienced and diverse ISO consultants
– Regular updates, provided through IMSMLoop
– Flexible terms and contract
– Fixed fee
– Full implementation

Contact Us

For a free Quotation or On-Site presentation by an ISO Specialist, contact us today!

Pacific Heights Investments 212 Pty Ltd.
2nd Floor, Office 46,
102 Stephen Dlamini Road,
Musgrave, Durban 4001

Tel: 0101575017

Contact Us

For a free Quotation or On-Site presentation by an ISO Specialist, contact us today!

Pacific Heights Investments 212 Pty Ltd.
2nd Floor, Office 46,
102 Stephen Dlamini Road,
Musgrave, Durban 4001

Tel: 0101575017