Medical Devices

Empower Your Medical Device Company: ISO 13485:2016 Awareness Training for Top Management Elevate your medical device company's standards with our comprehensive ISO 13485:2016 Awareness Training tailored for top management.

Empower Your Team: ISO 13485:2016 Awareness Training for Shop Floor Employees Empower your shop floor employees with the essential knowledge and skills required to uphold the highest standards of quality and compliance in the medical devices industry.

ISO 13485:2016 Consultancy ISO 13485 Background

ISO 13485 specifies the requirements for a quality management system for medical devices. In the medical devices industry, organization have to comply with the customer requirement and most importantly, meeting the applicable regulatory requirements relevant to the specific medical devices.

Learn ISO 13485:2016 Medical Devices QMS  Unlock the intricacies of ISO 13485:2016 Interpretation Training in the realm of Medical Devices Quality Management Systems (QMS) with our course. Our expert-led sessions delve deep into the nuances of the ISO 13485:2016 standard, providing you with the basic knowledge necessary to navigate its complexities effectively.

GDPMD is the Regulatory requirements for Medical Device Safety & Performance. In the Medical Devices Regulation 2012, Appendix 4 – Requirements on the Quality Management System, it specifies that Authorized Representative, Importer and Distributor is required to certify under GDPMD.

Gain Proficiency in ISO 13485:2016 with Comprehensive Training Equip yourself with the essential skills to interpret and implement ISO 13485:2016 standards effectively with our specialized training program.

Master ISO 14971:2019 Compliance with Expert Medical Device Risk Management Training Ensure regulatory compliance and enhance patient safety with our comprehensive ISO 14971:2019 Risk Management Training for Medical Devices.

Elevate Your Expertise with ISO 13485:2016 Internal Auditor Training Unlock the potential for excellence in medical devices Quality Management System (QMS) with our comprehensive ISO 13485:2016 Internal Auditor Training.

Unlock Compliance Excellence with Our Comprehensive Training Gain mastery over FDA 21 CRF Part 820 Quality System Regulation (QSR) with our specialized training program tailored for professionals in the medical devices industry. Our course is meticulously designed to provide in-depth understanding and practical insights into navigating the complexities of QSR compliance.

Course Objective:

• Understanding the GDPMD requirements
• Awareness on the key elements to ensure medical device quality and safety along the supply chain.

Optimize Compliance and Performance with Expert Process Validation Training Empower your team with the knowledge and skills needed to excel in process validation for medical devices through our specialized training program.

Course Objective:

• Understanding of the GDPMD requirements
• Understanding the audit principles
• Plan, conduct, report and close out an internal audit

Expert Software Validation for Medical Devices: Ensure Compliance with ISO 13485 and FDA requirements Empower Your Team with Comprehensive Medical Devices QMS Training
Stay ahead of regulatory requirements and ensure the reliability and safety of your medical devices with our expert Software Validation for Medical Devices.

Comprehensive Understanding of Medical Device Law in Malaysia Training  Overview:
Gain invaluable insights into the intricate legal landscape governing medical devices in Malaysia with our comprehensive training program.