Channel Avatar

Brandwood CKC @UCALTraSXfSnc49sA0qXD_TQ@youtube.com

635 subscribers - no pronouns :c

PharmaLex is a leading provider of specialized services for


41:40
Get Your Device In Control June 2021
37:29
Criticality of Medical Device Risk Management for Patient and Product Safety
46:26
Innovative Product Regulatory Strategies and Considerations for Medical Devices and IVDs
37:13
Medical Device Sponsorship Requirements for Australia and New Zealand
44:10
FDA Guidances in 2020: A high-level pharma, device and diagnostic overview
01:15:05
Global Medical Device and IVD Regulatory Changes in 2020 and Their Impact to Asia Pacific.
43:41
Top FAQs for 2020
22:32
Hitting the Accelerator October 2020 Webinar
45:44
Medical Device Regulations Under COVID-19. What you need to know.
39:31
Blood, Sweat and Tears - An Update to In Vitro Diagnostics Regulatory Requirements World Wide
38:45
Medical Device Software: Current Developments in the Regulatory World
28:53
Clinical Evaluation Report Webinar June 2020
02:57
Keeping it clean: Regulation of Hand Sanitisers as Cosmetics or Therapeutic Goods
20:29
Faster Australian Medicine Approvals by Leveraging International Evaluations - May 2020
01:09
Latest Update on Ventilators_April Webinar
39:54
Emergency approvals – moving things along in a Pandemic
29:27
BIOCOMPATIBILITY Webinar March 2020
21:42
Nobody Complained! Post market reporting under MDR
30:20
Harmonisation - Triumphs and Tragedies
53:36
The Case For Quality
01:02:35
Documentation Deconstructed – Understanding Risk Management
57:39
Time to get serious on postmarket
58:34
Documentation Deconstructed: Understanding the Technical file
57:20
How to survive the Perfect Storm – International Harmonization and Lessons from Brexit and the MDR
58:12
A Bulletproof Clinical Evaluation Report: Making them stand up to regulatory scrutiny
51:02
Biocompatibility Challenges for 2019
01:06:53
Making American Guidance Understandable Again
01:00:43
Why MDSAP opens a world of opportunity.
57:28
FDA and ISO stars aligning on ISO 10993
45:47
Taking a 510k Down Under…leveraging US and Canadian and Japanese approvals for TGA registration
51:11
1808 Webinar Recording the MSAC Process and What applicants need to know
49:30
Verification of 3D printed devices: Biocompatibility, Biomechanics and Sterilisation
54:33
Market Access in Australia – leveraging international approvals for TGA registrations
46:32
The Taiwan Fast Track: How US and European Approvals accelerate Taiwan FDA approval
59:02
Do I really need that clinical trial? A global approach to clinical evidence
54:52
China's New Year Resolutions - Brandwood Biomedical Webinar
38:08
The Oriental Express: The rapid evolution of China regulation
01:00:26
Webinar (Feb 2017) Postmarket Compliance ISO 134852016 & New European Medical Device Regulations
36:43
Managing a pan pacific product portfolio - in house, or outsourced?
53:04
Webinar Harmony with Strength: Regulatory updates in China March 2014
44:47
Australian Regulatory Requirements for Medical Devices
59:22
Webinar Understanding the Current Regulatory Landscape in China
46:40
Australia’s “Fast Track” pathway of device registration for local manufacturers
50:26
Webinar on Australian Reimbursement: The true costs and benefits of market entry
38:52
De-Risking Regulation Filings through Pre-submissions
46:40
Traps for the unwary on quality systems – design controls before you manufacture
26:00
Clinical Trials Down Under - Skipping regulatory approvals!
02:13
Brandwood Biomedical Asia Pacific Device Summit 2016
51:30
Webinar (Feb 2016) China Update - Whats New from CFDA?
51:29
Webinar (May 2016) Medical Device Regulations in Australia
59:13
Webinar (July 2016) Getting Paid for your device reimbursement strategy in US & UK
45:31
Webinar (June 2016) Clinical Evidence Requirements across multiple markets
18:39
Webinar (Oct 2016) Biocompatibility - A Risky Business
28:34
Webinar (Sept 2016) - Asia Pacific Product Labeling Tearing down the Tower of Babel
58:20
Webinar (Aug 2016) China Update - Whats New from CFDA?
39:13
Webinar Jan 2017 Changing Landscape for Medical Technology Reimbursement in Australia
38:34
Webinar March 2017 Tips for Taiwan
55:04
Building a Technical File - Brandwood Biomedical Webinar
41:34
What’s Up Down Under? Regulations and Reimbursement in Australia
28:47
China Thinks Again on Foreign Clinical Data