Best Regulatory Oversight for Off-Shore Device Manufacturing?

Watchcat

Watchcat

Trusted Information Resource
Of the countries that tend to be home to contract manufacturers rather than specification developers, which ones do you think have the best regulatory oversight of their medical device contract manufacturers?
 
Watchcat

Watchcat

Trusted Information Resource
PS I'd really, really appreciate it if no one turned this thread into yet another COVID-19 China rant.

Thanks.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
somashekar Which Medical Device Regulatory Body you rate as the best Other Medical Device and Orthopedic Related Topics 6
H Best place to keep myself updated on EU Regulatory Changes EU Medical Device Regulations 7
B Best quality / regulatory magazine subscription? Book, Video, Blog and Web Site Reviews and Recommendations 11
D Section 10: Improvement Best example from auditor perspective ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Best ISO9001:2015 Auditing Company in Chicagoland? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
T What is the best way to record an improvement activity or Kaizen? Lean in Manufacturing and Service Industries 8
R Changing our DMS/ECM to a Wiki. Advice on best practices and changes of paradigm? Document Control Systems, Procedures, Forms and Templates 0
T Management review - how do you do your meeting? to get best response and involvement? and outputs Quality Manager and Management Related Issues 20
K Best automation presentation software Manufacturing and Related Processes 0
K Best Internal Auditor Training Internal Auditing 18
M When is the Best Time to Initiate PFMEA? ISO 13485:2016 - Medical Device Quality Management Systems 11
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
J Best Practices for Choosing In-process Inspection Dimensions & SPC Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
G Seeking reference guides/ documentation /tips on verification best practices Other Medical Device Related Standards 6
D Ultra low freezer thermometers, best practices? ISO 13485:2016 - Medical Device Quality Management Systems 8
S Question: Best alternatives to audits for ensuring compliance Quality Tools, Improvement and Analysis 5
PQ Systems Best Practices In Gage Management Using GAGEpack Software 0
Q Best off presentation of process flows Process Maps, Process Mapping and Turtle Diagrams 16
Q Best country to import medical devices into Europe Other Medical Device and Orthopedic Related Topics 0
M Best accreditation body for AS9100D Lead facility auditor? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
G Best way to calc uncert for measuring microscope without duplicating repeatability? Measurement Uncertainty (MU) 2
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
optomist1 Best Optical Comparators General Measurement Device and Calibration Topics 9
qualprod Best practice to ensure inputting of data in production Lean in Manufacturing and Service Industries 19
M Best profilometer for the money General Measurement Device and Calibration Topics 22
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 4
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 12
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
S What is the best method to bond urethane foam to urethane foam? Manufacturing and Related Processes 4
E Best way to keep up with pharmaceutical quality knowledge and current affairs Service Industry Specific Topics 1
K Best Measurement Systems Demos in California? General Measurement Device and Calibration Topics 1
qualprod Best approach to get a real value as average? Statistical Analysis Tools, Techniques and SPC 6
CPhelan Best metrics for monitoring low volume (<1000) parts per vendors Supply Chain Security Management Systems 1
DuncanGibbons Best practice for identifying "items" of parts for DFMEA analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
I What kind of wine best complements the Friday that you close out your external audit findings? Opinions are welcome. Coffee Break and Water Cooler Discussions 12
I Non-Conformance vs OFI -- your best descriptions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 61
A What are Practical data center best practices IEC 27001 - Information Security Management Systems (ISMS) 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
S Best software for customer support/complaints? Customer Complaints 0
R Bill of Materials for a complex product - Industry best practice ISO 13485:2016 - Medical Device Quality Management Systems 2
G Oversized Threads - What sized stab pin would be best to quickly check for oversized thread holes General Measurement Device and Calibration Topics 5
D What is the best software used for the pharma compliance management? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M Informational MHRA launches consultation on how to best engage patients and the public Medical Device and FDA Regulations and Standards News 0
optomist1 Mobility Field Manufacturing Best - Worst Practices Manufacturing and Related Processes 5
qualprod Best criteria to measure Corrective Action effectiveness - Poor Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N Best practices for capturing audit objective evidence in a practical manner? Internal Auditing 3
S How to Learn all aspects of ISO 27001:2013 | The best way to grab the knowledge on 27001:2013 (Step by Step) IEC 27001 - Information Security Management Systems (ISMS) 7

Similar threads

Top Bottom