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Let's talk pharmaceutical, global medical devices + IVD regulatory servicesEpisodes
Brandwood CKC
Let's talk pharmaceutical, global medical devices + IVD reg…
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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 implementat
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 cri
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 th
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
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 b
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 regul
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 diag
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 diag
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 th
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 equ
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 prepa
This webinar will provide an update to our 2019 webinar on Software as a Medical Device (SaMD) and Software in Medical Devices. Yervant Chijian will highlight recent regulatory changes as they apply to Medical Device software and how businesses
As regulators around the world look more closely at the Clinical Evaluation Report in support of a device’s safety and efficacy, we revisit the key aspects of discussion on which manufacturers and sponsors should focus their efforts.Listen in t
The Australian Therapeutic Goods Administration recently implemented several new initiatives that enable sponsors to utilise regulatory approvals from other jurisdictions (e.g. USA, Canada, Europe) to accelerate prescription medicine approval i
With disrupted supply chains, shortages of medicines, masks, ventilators and test kits, everyone wants the regulator’s attention – right now, today. The good news is that pandemic planning has been a thing for regulators for many years. And the
As the ISO Technical Committee 194 prepares to meet later this year, we look at the planned changes to the standards, the rising prominence of chemical characterisation and the efforts to eliminate animal testing.Join James Morrison and Jean Bo
With just a few months to go to the MDR transition deadline, manufacturers will be subject to a raft of new formal postmarket reporting requirements. And they all rely on active data collection. Inadequate monitoring leaves a manufacturer defen
Learn how Australia does faster drug approvals through shared evaluations and leveraging international approvals. How to minimise risks from the European MDR devices train wreck and the growing trend for “Reliance” as CE mark becomes harder and
For our last webinar of the year, we are honoured to have a special guest: Francisco Vicenty, Program Manager, Case for Quality US FDA/CDRH/Office of Compliance join us.The Case for Quality is a program developed under the auspices of the Medic
Although Medical Devices are of more immediate focus with the implementation of the MDR, it is possible that the changes for IVD devices in Europe may be even more significant and burdensome. Having a plan early over the next two years will be
Rapidly changing technologies and access to software through connected platforms have blurred the lines between consumer and medical products.This has historically resulted in some challenges for healthcare regulators and Industry to recognize
For years regulators have talked about the importance of continuing monitoring and follow up of approved devices – so called Postmarket Regulation, or Vigilance in Euro-speak.But frankly, industry focus and regulator resources have always been
Good documentation is about doing it once. We explore how to use the Design Controls to build a core Technical File, and to use it to create DHF, DMR, Design Dossier and regulatory filings such as 510(k) and PMA. We will also explore the impact
This month we look at global regulatory strategy in times of uncertainty. Remember just yesterday when CE was a smooth and quick process and CE mark gave a passport to so many other markets. Suddenly everything changed. We look at what the impl
As Europe transitions to the MDR and TGA focuses more on clinical evidence in applications, creating a Clinical Evaluation Report (CER) that meets all regulators’ expectations seems like an impossibility. Understanding MEDDEV 2.7/1 revision 4 i
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