Greenlight Guru
Greenlight Guru is the #1 provider of modern cloud-based solutions for the MedTech industry, helping companies bring life-changing products to market faster, more efficiently, and with less risk.Greenlight Guru’s MedTech Suite provides quality management, product development, and clinical data management solutions, along with high-quality training and education required to keep up with the rapidly changing industry regulations.
Trusted by over 1,100 medical device companies across the globe, Greenlight Guru has been named by G2 as the #1 Medical QMS Software and by the Inc Magazine as a Best Place to Work. For more information, visit www.greenlight.guru.
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- 3 ай бұрын
Refuse to Accept & Additional Information Request: Avoiding Problems with Medical Device Subm...
- 56:02
- 3 ай бұрын
Demystifying FDA’s Pre-Market Final Guidance
- 1:31:15
- 3 ай бұрын
Change Management and Risk Management: How Do We Connect the Dots and What Happens if We Don’t?
- 1:20:22
- 3 ай бұрын
Bridging the Gap Between Development and Regulatory Teams
- 1:05:20
- 3 ай бұрын
How to Apply Risk Management Throughout the Product Lifecycle of Your Medical Device
- 1:15:30
- 4 ай бұрын
How to Survive an FDA Inspection
- 59:37
- 4 ай бұрын
Alternatives to PMCF Clinical Investigations
- 1:30:26
- 4 ай бұрын
Understanding the Medical Device Classification System
- 1:30:12
- 4 ай бұрын
Letter to File 101: Are You Sure You're Preparing Yours Correctly?
- 1:31:24
- 5 ай бұрын
Usability Testing: Why Can’t We Get It Right?
- 58:05
- 5 ай бұрын
When Design Input Requirements Go Wrong
- 59:23
- 5 ай бұрын
Prepping your QMS for EU MDR
- 1:27:35
- 5 ай бұрын
Evaluating the Need for Biocompatibility Testing & Mitigating Risks when Changing a Medical D...
- 44:08
- 5 ай бұрын
Demonstrating Conformity to General Safety and Performance Requirements GSPR under MDR
- 1:32:00
- 5 ай бұрын
UDI Product Data and EUDAMED, Get Onboard!
- 1:23:02
- 5 ай бұрын
Insider’s Look at the IEC 60601 Amendments: Guidance from Committee Member Responsible for Changes
- 1:25:43
- 5 ай бұрын
The “New” 510(k): How Do You Show Substantial Equivalence without Using a Predicate?
- 1:10:58
- 5 ай бұрын
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