Medical Device News NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application”

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Sam Lazzara Time Zero testing in med device aging studies Qualification and Validation (including 21 CFR Part 11) 3
V Need of EU representative if CE marked Med Device not marketed in Europe EU Medical Device Regulations 8
SteveK NB-MED, NBOG, IMDRF and MEDDEV hierarchy EU Medical Device Regulations 3
M Guidance for Medical Device Registration in Med Dev Regulations World-Wide Other Medical Device Regulations World-Wide 22
T NB-MED 2.5.2-Rec 2 interpretation EU Medical Device Regulations 1
T Has NB-MED 2.5.2-Rec 2 Version 8 been withdrawn? EU Medical Device Regulations 10
Ronen E FDA publishes Draft Guidance on Med Dev Pre-Submission Program and Meetings with FDA Other US Medical Device Regulations 0
S New Draft FDA Guidance - Human Factors & Usability Engineering for Med Device Design US Food and Drug Administration (FDA) 0
G RoHS Changes Coming in 2012? Expansion to include med device, IVD's, analyzers? RoHS, REACH, ELV, IMDS and Restricted Substances 3
M Massachusetts' New Med/Pharma Marketing Law...Leading Edge Various Other Specifications, Standards, and related Requirements 0
L FDA CAPA Requirement for Contract Med. Dev. Manufacturers Other US Medical Device Regulations 4
J Material standards for med-tech gloves EU Medical Device Regulations 8
S FDA approval (Med Device) - Should we use Accredited Person or proceed on Our Own? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ajit Basrur FDA Proposes Guidance for Dissemination of Info on Unapproved Uses of Med Products US Food and Drug Administration (FDA) 0
T Looking for an accredited FDA MED-DEV 3rd Party Auditor ISO 13485:2016 - Medical Device Quality Management Systems 4
E Need an ISO 9001/14001/13485 Quality Manual - Many suppliers - Pharma and Med Devices Quality Management System (QMS) Manuals 7
D Quality Team Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 15
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
C Neglect or legitimate deferral? Is excessive workload or lack of resources in a department or a team a valid root cause for a non-conformance? Problem Solving, Root Cause Fault and Failure Analysis 12
K AS9100D 8.4.1.1 external providers question - Walmart, Home Depot, our lawn care team. etc. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 20
K APQP Phase 3 - Team Feasibility Commitment APQP and PPAP 3
M Informational Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued Medical Device and FDA Regulations and Standards News 0
R How to SHOW the importance of checklists, through some team gaming or play? Training - Internal, External, Online and Distance Learning 37
I ISO 9001:2015 - "Resources" - handled by leadership team? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Informational Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs Medical Device and FDA Regulations and Standards News 0
M Medical Device News Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation – Regulation (EU) 2017/746 Medical Device and FDA Regulations and Standards News 0
M Does a CDR (Critical Design Review) have to have a moderator that is unconnected to the team? Design and Development of Products and Processes 4
M Medical Device News EU MDR – Information on stages in designation process from Team-NB Medical Device and FDA Regulations and Standards News 5
M Position paper Team NB Statement - Patient safety EU Medical Device Regulations 0
A KPI for Quality Assurance Team in a Service Oriented Industry Service Industry Specific Topics 8
T ISO 9001:2015 Training for Management Team in NM - Seeking Suggestions and Providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A What KPI's do you use at Shop Floor Level and Team Boards? Quality Tools, Improvement and Analysis 4
W Connecting IndySoft MET/CAL Import Module to a Fluke MET/TEAM Calibration and Metrology Software and Hardware 1
Q IATF 16949 Strategy - Audit Team Requirement IATF 16949 - Automotive Quality Systems Standard 4
M Seeking opinion for ISO14001 team activity ISO 14001:2015 Specific Discussions 3
D Could an Accountant be a PPAP team leader ? APQP and PPAP 2
C Implementing ISO 9001 - Getting whole team buy-in? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
J Employees regard the QA team as the "enemy" Misc. Quality Assurance and Business Systems Related Topics 20
P Supplier Scorecard for ISO 9001 - Help me review the draft from my purchasing team ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Can you Suggest KPIs for a Business Process Improvement Team? Pls. Benchmarking 4
J Is anyone here using Metcal / Met TEAM (8.1) Calibration and Metrology Software and Hardware 1
bio_subbu TEAM-NB Issues - FAQ related to Implementation of EN 62304 with respect to MDD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Management Team "Actions" vs. CAPA (Corrective Actions) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
C Setup Time Reduction Project - How big should my team be? Six Sigma 2
C When do I select Team for Black Belt Project? Six Sigma 3
V Improvement Plan for existing QUALITY TEAM Quality Manager and Management Related Issues 6
Wes Bucey Is there an "i" in TEAM? Funny Stuff - Jokes and Humour 16
K Recognition of team members in ways other than money? Customer Complaints 5
D PFMEA and Control Plan Core Team Changes FMEA and Control Plans 4
Similar threads


















































Top Bottom