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
cscalise RAPS/Med Dev EU MDR Guidebook - Reviews or Opinions? EU Medical Device Regulations 0
CharlieUK Informational ADCO MED EU DECLARATION OF CONFORMITY TEMPLATE CE Marking (Conformité Européene) / CB Scheme 0
H Where to get EK MED 1927/16 Other Medical Device Regulations World-Wide 3
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
S 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 24
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T Has NB-MED 2.5.2-Rec 2 Version 8 been withdrawn?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Ronen E FDA publishes Draft Guidance on Med Dev Pre-Submission Program and Meetings with FDA Other US Medical Device Regulations 0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
G Team to analyze a non conformance Customer Complaints 26
Marc BP Slashes Its Oil Exploration Team by 85%, Starts Switching to Renewables World News 11
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
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 17
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, NADCAP and Aerospace related 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

Similar threads

Top Bottom