4.2.4.6 - Computer-aided design - Cad-type program for tooling drawings?

D

Dawn

#1
#1
4.2.4.6 "The supplier shall be able to use numerical design and drawing data, by computer-aided methods, for the manufacture of production tooling, and prototypes as applicable."
Does this mean it is a shall to have a Cad-type program for tooling drawings?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Suggest Computer Aided Quality Assurance (CAQ) software for Medical Devices Quality Assurance and Compliance Software Tools and Solutions 3
X Computer-Aided Detection for Mammography - Class A, B or C? IEC 62304 - Medical Device Software Life Cycle Processes 5
M Need advice to implement CAPP (Computer Aided Process Planning) change. Manufacturing and Related Processes 4
A Use of Computer Aided Learning for Quality Topics - E-Learning Training - Internal, External, Online and Distance Learning 20
P Blood establishment computer software EU classification EU Medical Device Regulations 0
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Computer System Validation of Bioinformatics Pipeline Qualification and Validation (including 21 CFR Part 11) 5
M Informational USFDA Draft Guidance – Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Medical Device and FDA Regulations and Standards News 0
F EMC testing for a system that is provided with a computer IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
D Use of password managers on validated computer systems (21 CFR Part 11) Medical Information Technology, Medical Software and Health Informatics 2
L How to classify this computer-alike IT device EU Medical Device Regulations 2
U CE Marking of Customized Ruggedised Computer Systems Solutions CE Marking (Conformité Européene) / CB Scheme 5
Tagin Can/should SPC be applied to Computer Assembly and Software Imaging? Statistical Analysis Tools, Techniques and SPC 8
Q ISO 9001 Section 7.6 - Computer Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Computer stations unlocked - Office Stations vs Production Stations Supply Chain Security Management Systems 4
howste ASQ is Transitioning to Computer Based Exams ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 13
R Network/Computer Data Migration Sampling GMP Software Quality Assurance 1
E Computer System Validation - Migrating to SAP Document Control Systems, Procedures, Forms and Templates 5
D SDS (MSDS) for complex products such as a TV, computer, cars, etc Miscellaneous Environmental Standards and EMS Related Discussions 3
N Computer System Access and Security Procedure example wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q The ability of computer software to satisfy the intended application ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Strategy to allow for OTS computer use as part of a Medical Equipment System EU Medical Device Regulations 14
D Validation of Computer and Network Equipment Test System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
Gman2 Control of Documents and (FORMS) on a Computer Network ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
H ISO 9001:2008 Clause 7.6 Control of Monitoring and Measurement (Computer Software) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Computer System for Inspection Balloons in Technical Drawings Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
T Class II Medical Device with Software - Change to Computer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Is a computer used in hospitals considered a medical device? ISO 13485:2016 - Medical Device Quality Management Systems 17
Marc Shopping for Computer Spyware After Work and Weekend Discussion Topics 4
Q 21 CFR 820.30 - Automated with Computer Software - Applicable? US Food and Drug Administration (FDA) 5
M Options for OTS Computer as part of Medical Equipment System IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
A Is Computer Helpdesk a Special Process ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Marc Computer Viruses Are "Rampant" on Medical Devices in Hospitals World News 0
I Confirmation of Computer Software to satisfy Intended Application Misc. Quality Assurance and Business Systems Related Topics 2
N Complying with ISO 9001 7.6 - Customer Provided Computer and Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
E Gages on Computer Screens General Measurement Device and Calibration Topics 2
Marc Life after the Personal Computer After Work and Weekend Discussion Topics 14
F Traceability Requirements for Computer Hardware Equipment under ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
B Computer Monitoring - Our company is implementing keyloggers IEC 27001 - Information Security Management Systems (ISMS) 11
N 7.5.2.1 Validation of the Application of the Computer Software - PLEASE CLARIFY ISO 13485:2016 - Medical Device Quality Management Systems 9
A Best Way for SPC via Optical Comparator with output to Computer for Data Analysis Statistical Analysis Tools, Techniques and SPC 4
K Malware affecting my computer operation After Work and Weekend Discussion Topics 19
S Computer Simulation Validation Tests for Underwater Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
K I.T. Management in Clause 4.2.3? Control of Computer Data Backup and Access Security ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I CE Mark for Standalone Medical Computer Monitoring Software IEC 62304 - Medical Device Software Life Cycle Processes 5
Marc AIDS Puzzle Solved By Computer Gamers World News 1
M Medical Diagnostic Equipment Control Computer Repair Other US Medical Device Regulations 3
R Medical Device FDA - Classification of a device used as an interface with a computer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Medical Device Manufacturer Document Control Computer System Validation Qualification and Validation (including 21 CFR Part 11) 4

Similar threads

Top Bottom