21:16
Preparation for the In Vitro Diagnostic Regulation IVDR 2017/746
Easy Medical Device
42:06
OEM & OBL Model with the new MDR & IVDR - PART 1
35:45
EU MDR & IVDR Notified Body Situation with Erik Vollebregt
48:15
How to choose your PRRC ? (EU MDR 2017/745 - IVDR 2017/746)
32:44
What are the new rules for In-Vitro Diagnostic Industry with IVDR 2017/746?
28:13
Medical Device disruptions at Hospitals with Stefan Krojer (MDR & IVDR)
13:59
How to lead a MDR or IVDR project without issue (Pitfalls)
32:42
What should Medical Device Manufacturer do as EUDAMED is Delayed (MDR 2017/745)
29:02
Distributor role within MDR and IVDR with Nicolaj Nitzsch
26:01
Introduction to MDR EUDAMED by Richard Houlihan (MEDICA 2019)
33:57
How to create a Quality Management System compliant to MDR and IVDR?
1:03:09
The best tips to build an MDR / IVDR Project? (Medical Device Regulation)
8:51
Medical Device School - Who are the Economic Operators? (MDR & IVDR)
32:08
Why do we have Brexit, Swixit & Turkxit ? Erik Vollebregt (MDR & IVDR)
7:59
Who controls the Economic Operators with Erik Vollebregt (MDR & IVDR)
1:20:58
What are the changes to ISO 14971 2019? (REPLAY) #medicaldevice
13:03
What should verify the Economic Operators? (EU MDR and IVDR)
38:05
Create the Intended Purpose for your Medical Device with Cesare Magri
8:05
Do Economic Operators need a Quality Management System ? (EU MDR IVDR)
21:48
Medical Device Regulatory Update - February 2020
37:29
#Cybersecurity for Medical Devices with Erik Vollebregt (MDR & IVDR)
59:52
Clinical/Performance evaluation for Medical Device Software (MDR IVDR)
1:11:19
How to comply to the GSPR ? (EU MDR and IVDR - Monir El Azzouzi)
45:21
Greenlight Guru Virtual Summit: Economic Operators under EU MDR & IVDR
35:25
Medical Device News - May 2020 Review
24:48
Medical Device News - June 2020 Update
35:37
I Want To Become a PRRC with TEAM-PRRC (EU MDR & IVDR)
31:26
Understand IEC 62304 for Software Medical Devices with Adnan Ashfaq
35:54
Learn UDI code with Sylvia Reingardt (EU MDR 2017/745 & IVDR 2017/746)
22:58
Medical Device News - July 2020 Update - EU MDR and IVDR
19:05
Medical Device News - August 2020 review (without Clip)
44:47
Ready for a successful MDR or IVDR Audit (Martin Witte - TÜV SÜD)
42:40
How GDPR impacts the Medical Device Industry with Erik Vollebregt
26:38
Let's talk Brexit, Swixit, Conferences, MDSAP [Medical Device News Sept 2020]
25:12
Q&A Session - No more secrets on Economic Operators [MDG Premium call]
How to regulate Self Testing with the new IVDR 2017/746?
27:58
Last 2 years stories for the Medical Device industry [Episode 100]
25:18
What are Common Specifications within MDR & IVDR? [Stefan Bolleininger]
24:03
How to register your company in EUDAMED? [Medical Devices]
32:06
Medical Device News - November 2020 update
20:38
How to deal with Significant Changes for your Medical Devices (EU MDR)
21:27
How Easy Medical Device can help you? (Monir El Azzouzi)
27:08
Medical Device News - January 2021 (EU, Brexit, MDCG, Notified Body)
26:52
When should you apply the MDR in Europe ? [Medical Device Regulation]
1:00:05
Remote Audit are authorized for EU MDR but..... [Stefan Bolleininger]
28:54
How to import your Medical Devices with an Independent Importer?
59:11
EUDAMED Question & Answers with Richard Houlihan (Live Session)
38:52
How System and Procedure Pack are regulated under EU MDR? [Erik Vollebregt]
1:03:41
How to create your UDI with Sylvia Reingardt from GS1
21:12
Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
25:55
Medical Device News - April 2021 Update [Monir El Azzouzi - Easy Medical Device]
37:20
How to write your Performance Evaluation [IVDR 2017/746]
40:19
Merger and Acquisition during the MDR transition with Erik Vollebregt
21:47
Medical Device News - May 2021 Update
44:41
Brace yourself - MDR is Coming with Erik Vollebregt
23:56
The industry's opinion on EU MDR with Catherine Higginson
35:18
Medical Device News - June Update 2021 [EU MDR date of Application]
42:04
How to build your State-of-the-art for your Clinical or Performance Evaluation?
30:02
MEDICAL DEVICE NEWS: July 2021 Update
34:35
How to interpret the First Expert Panel Opinion? [Bassil Akra]
45:54
System and Procedure Pack Producer the Return with Erik Vollebregt
25:36
Medical Device News - August 2021 Regulatory Update [MDR & IVDR]
40:10
What can we learn from the first MDR audits with Martin Witte (TÜV SÜD)
29:26
Medical Device News - September 2021 Update
33:25
Why would you sue your Medical Device Notified Body? [Erik Vollebregt]
26:43
How should you manage the IVDR transition period for your device? [IVDR 2017/746]
34:48
Medical Device News - October 2021 Regulatory Update
44:22
Big Eudamed Update: Should you register now your Medical Devices?
Breaking News - EU Proposal to delay some of the IVDR Date of Application
34:49
Medical Device News - November 2021 latest update
50:17
What are Cybersecurity requirements under EU MDR?
33:50
Is Own Brand Labelling (OBL) still possible with MDR or IVDR?
43:21
Which strategy to adopt with your Notified Body? [Dr Royth von Hahn]
55:01
Is it the end of In-house devices? [IVDR 2017/746]
29:54
Medical Device News - December 2021 Regulatory Update
29:03
The Step-by-step method to get MDR - IVDR Certified
29:46
Medical Device News - January 2022 Update
43:12
MDCG 2021-27 - Placing on the market & relabelling with Erik Vollebregt
26:51
Why do we need IVDR Class D Common Specification with Andreas Stange
28:47
How to sell Medical Devices Online ? [EU and FDA]
43:27
MDR & IVDR transition + Expert Panel Handover to EMA with Erik Vollebregt
24:44
Medical Device News- April 2022 Regulatory Update
28:35
How to prepare your Audit with a Front Room & Back Room? [Medical Devices]
25:13
Medical Device News: May 2022 Regulatory Update
18:54
With MDR & IVDR they created a Monster. Who is driving it? #MTF2022
32:12
What happens after the IVDR Date of Application [Colm O’Rourke]
26:05
What did we learn about the EU Medical Device Situation at Medtech Forum?
1:03:55
EU MDR & IVDR PRRC feedback after 1 year
23:31
Medical Device News - June 2022 Regulatory update
29:50
How to create your Medical Device Technical File [EU MDR & IVDR]
36:18
CE Marking: New versions of Blue Guide: What impact to Medical Devices?
33:46
Medical Device News - September 2022 Regulatory Update
38:18
How to become the Best PRRC Ever? [EU MDR & IVDR]
I help you select your Notified Body & understand the full process
25:10
Software and IVD clinical evidence are WRONG!!! [Cesare Magri]
30:43
Medical Device News - November 2022 Regulatory update
38:42
Medical Device: All about the role of PRRC [Team PRRC event]
27:29
Medical Device news - May 2023 Regulatory Update
36:27
MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update
20:45
Interviews on Being The PRRC (Part 2/2)
31:31
What are the EUDAMED Updates?
33:18
MEDICAL DEVICE NEWS October 2023 Regulatory Update
Afrisummit 2023 Interviews Part 1
31:11
Afrisummit 2023 Interviews Part 2 – Egypt Situation
16:44
How to find a Notified Body for EU MDR or IVDR
43:03
What is the impact of AI Act on Medical Devices?
36:16
Why and how to build a Quality Culture? (Lesley Worthington)
36:25
Medical Device News - May 2024 Regulatory Update
29:59
Quality Field Service for Medical Devices?
30:47
How to select and evaluate your Contract Manufacturer?
49:19
Are you more Corrections or Corrective Actions or Preventive Actions?
44:00
Medical Device Usability - Summative Evaluation – Common mistakes
