In this webinar, we navigate you through the design control requirements of the main regulators. Discuss the design and development process for medical devices, including software. Share our experience and provide practical tips for implementation into your quality management system to produce reliable documentation which demonstrates regulatory and quality compliance ..read more

Regulatory bodies have emphasised the importance of Risk Management under ISO 14971 in the development of medical devices and in-vitro diagnostics. In this webinar, led by Senior Consultant, Yervant Chijian we explore how Risk Management is critical to regulatory frameworks and provide an overview of the fundamental principles and key standards. In addition, best practices for implementing risk management activities within your organisation including post-market considerations will be discussed and outlined. Presenter: Yervant Chijian, Brandwood CKC ..read more

As the global medical practice undergoes drastic change embracing faster access to innovative technologies, getting the regulatory strategy right from the onset can mean the difference between success and failure. In this webinar, we discuss the key considerations for registering innovative products and changes to existing products incorporating innovative modifications. We will focus on the current regulatory issues and requirements when evaluating alternative pathways for TGA, EU, and the US including rare-disease designations, priority review, and provisional approvals. Special note will be ..read more

Medical device and IVD manufacturers who wish to distribute their products in Australia and New Zealand need to appoint a local sponsor. In this webinar, Brandwood CKC Consultant, Orsola Regaglia, covers the key requirements of Sponsors for TGA and MedSafe, their role in the premarket and postmarket phases. We provide key recommendations for manufacturers and sponsors on how to select the right partner and effectively interacting between the main entities and the Regulators. Presenter: Orsola Regaglia, Brandwood CKC ..read more

2020 was a year like no other and COVID-19 has certainly challenged the Pharmaceutical, Medical Device and Diagnostic Industries. Even with all that was going on with COVID-19 and making COVID-19-related medical products available, 2020 was a banner year for guidances issued by the US Food and Drug Administration (FDA). In this month’s webinar, our Directors, Rob Stringer and Terrance Thiel will discuss those guidances that have the most impact on the pharma, medical device and diagnostic products, by providing an overview, understanding and examples of these guidances’ effects, including the ..read more

This webcast recording reviews the most salient global regulatory changes in 2020 for Medical Devices and Diagnostics and how they impact the Asia Pacific. Brandwood CKC’s TJ Thiel and John Lockwood of Pearl Pathways, delve into the major regulatory bodies’ most important regulatory changes and analyse the potential impacts on the Asia Pacific. There is also a focus on changes in Australia’s TGA, Japan’s PMDA, and China’s NMPA. Additionally, this presentation takes into account the impact the COVID-19 pandemic has had and how regulators have adapted regulatory changes to meet medical supply de ..read more

2020 has been a year like no other and COVID-19 has certainly challenged the Medical Devices Industry. In this month’s webinar Grant Bennett and T.J. Thiel will discuss the most frequently asked regulatory questions for medical devices and diagnostics in this 2020 year-end review. Several key topics will be covered, including disinfectants, leaflets/implant cards and adverse event reporting. Although the most frequently asked questions will be covered, there is an opportunity to have any of your specific questions answered – just be sure to submit them when registering. Presenters: Grant Ben ..read more

In recent times, the TGA has introduced a range of new prescription medicine application pathways that utilise overseas evaluations and accelerate market access. The team at Brandwood CKC have extensive experience with these new pathways and this webinar will outline the latest developments and provide insights as to the pros and cons of each pathway. A must for companies looking to accelerate Australian regulatory approvals and maximise efficiencies in the global roll out of new products. Presenter: Robert Stringer, Director and Principal Consultant ..read more

COVID-19 has challenged the health systems’ dynamics in many ways and industry and regulators have responded by implementing special actions to ensure patients and caregivers are provided with adequate diagnostics, therapies, and protective equipment. In this webinar, Orsola Regaglia and Jean Boudaud will present an overview of the response to COVID-19 from the regulators in key geographies. We will discuss pathways for COVID-related devices regulatory approvals and share our experience with the regulatory review processes. Presenters: Orsola Regaglia, Consultant and Jean Boudaud, Senior Consu ..read more

This podcast will provide an update to our 2019 webinar on In Vitro Diagnostic products, as well as current situations in US, Australia and other key geographies. Hear from TJ Thiel on recent regulatory changes and how businesses can best prepare for upcoming regulatory submissions for IVDs. Presenter: TJ Thiel, Consulting Operations Manager and Principal Consultant, Brandwood CKC ..read more