Medical Devices Webinars

• 60 Mins

The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in...

By Internal Team

• 60 Mins

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most...

By Internal Team

• 60 Mins

The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In a...

By Internal Team

• 60 Mins

Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are als...

By Internal Team

• 60 Mins

Some regulatory guidelines mention the need of a QMS. But every company should have a library for its biggest asset – the knowledge of the employees. The reason to have a QMS is not to satisfy the regulat...

By Internal Team

• 60 Mins

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration...

By Internal Team

• 60 Mins

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. The programme will cover the regulatory requ...

By Internal Team

• 60 Mins

Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating, and controlling potential risk...

By Internal Team

• 60 Mins

Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maint...

By Internal Team