Regulatory requirements for Active Medical Devices

A critical success factor for developing an active medical device (those with electronics hardware and software) is having a clear regulatory strategy. Having a clear pathway from concept, through clinical trials to regulatory acceptance in target markets guides the roadmap technological development. 

This 40-minute presentation will explore the compliance and certification requirements for creating and marketing active medical devices. The role of notification bodies such as the TGA, FDA, CE will be outlined along with the main regulatory standards, particularly those relating to active medical devices. 

The key activity of classifying your device is explained. We then set out the pathway to certification, including the role of predicate devices, verification and validation, clinical trials and the certification process.

This webinar will be presented by Heyam Kalla, a senior consultant at Brandwood CKC. Brandwood CKC is a consultant to biomedical industry on regulatory, quality systems and reimbursement strategies. The company has over 20 years of experience with offices in seven countries. 

Heyam Kalla is an experienced Medical Devices regulatory professional having held RA and QA roles in a multinational implant manufacturer. Heyam has particular expertise in preparation and review of clinical evidence reports for Australian and European markets. She is experienced in regulatory pathway, planning and strategy for ANZ markets, preparation of regulatory filings, management of regulatory reviews and postmarket compliance management for a variety of devices, Heyam has also served the Asian Harmonisation Working Party (AHWP), particularly in the area of preparation of guidance on electronic labelling. Heyam was awarded a Bachelor of Science with a double major in pharmacology and medical microbiology and immunology with first-class honours in pathology from UNSW.