Medical Devices

If you are a medical device/component/accessories manufacturer and aiming to include markets such as Europe, Africa, Japan, Taiwan, China or Australia-New Zealand, ISO 13485:2016 certification is must. To ensure you get certified through an accredited institution, we offer a step-by-step implementation of quality management system which includes:

• Pre-assessment
• Gap Analysis & Mitigation
• Audit support
• Training and
• Maintenance contract

We understand it is sometimes not necessary to build all the processes from scratch, but your existing quality system can be tweaked to meet the ISO requirements; this way, it is efficient in time and cost to your organization.