Manufacturers should develop a testing device for covid19

#1
In the wake of Covid-19, the medical device companies would like to suggest that manufacturers develop a more compact form of a testing device for covid19. They need to know how to apply the requirements of Design & Development to their service. I think all people should put their heads together and develop a perfect solution to overcome this crisis. If you have any suggestions or thoughts into this would be appreciated.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 2
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 0
dgrainger Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers Medical Device and FDA Regulations and Standards News 0
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
C ASL - Buying from unqualified manufacturers through qualified distributors Supplier Quality Assurance and other Supplier Issues 2
G Can calibrated device values be used instead of manufacturers spec? General Measurement Device and Calibration Topics 2
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 0
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
Q Purchasing requirements for Toll Manufacturers Manufacturing and Related Processes 1
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
DuncanGibbons Documentation aerospace OEMs require with purchase of parts from manufacturers/suppliers Manufacturing and Related Processes 0
M Informational FDA order – All manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distr Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment Medical Device and FDA Regulations and Standards News 0
I Japanese medical device recall requirements & procedure for foreign manufacturers Japan Medical Device Regulations 4
dgrainger EC-MDR Information for manufacturers guidance EU Medical Device Regulations 1
B Non Applications in ISO 13485:2016 for component contract manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 2
S Virtual manufacturers/OEM - CE/ISO requirements EU Medical Device Regulations 7
J Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer? EU Medical Device Regulations 13
P Requirements/guidance on what constitutes the Manufacturers "Address" EU Medical Device Regulations 7
M ISO TR 20416 Medical Devices - Post-Market Surveillance for Manufacturers Other Medical Device Related Standards 6
Ronen E Independence on Notified Bodies, inter alia of Manufacturers they Assess EU Medical Device Regulations 7
H Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU) ISO 13485:2016 - Medical Device Quality Management Systems 1
H Is Product Liability Insurance Compulsory for Medical Device Manufacturers? Other Medical Device Regulations World-Wide 2
JoCam Over-labelling the manufacturers name at the front of the device EU Medical Device Regulations 31
S Manufacturers Obligations for Medical Device Servicing and/or Repair EU Medical Device Regulations 10
U Are all manufacturers required to set up eMDR system? Other US Medical Device Regulations 4
S Is FDA Establishment Registration for Bulk packaging Contract Manufacturers ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q FDA Requirements for Contract Manufacturers and OTC products US Food and Drug Administration (FDA) 4
A One Medical Device - Two Legal Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 5
DietCokeofEvil How is it that gage manufacturers are not required to be accredited? General Measurement Device and Calibration Topics 9
T Are Customers required to follow a Manufacturers Maintenance Schedule? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Aerospace Manufacturers Label vs Certificate Quality Manager and Management Related Issues 6
H What is required to support changes to API Manufacturers in OTC Drugs? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
T IEC 62133 Certified Battery Manufacturers Other Medical Device Related Standards 3
C FDA requirements for Contract Manufacturers Document Control Systems, Procedures, Forms and Templates 1
T PPAP Requirements for Contract Manufacturers APQP and PPAP 4
M New Medical Device Contract Manufacturers Excise Tax Requirements US Food and Drug Administration (FDA) 8
Marc Guide To Inspections Of Medical Device Manufacturers - 1997 (06/08/2010) US Food and Drug Administration (FDA) 3
B DMR (Device Master Record) For Contract Manufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S Excipient Manufacturers - Supplier Risk Assessments when they refuse Customer Audits Supplier Quality Assurance and other Supplier Issues 5
K Applicability of ISO/TS 16949:2009 to Automotive Parts Manufacturers IATF 16949 - Automotive Quality Systems Standard 13
P CMC Decision 3 - Manufacturers Address Content Requirements EU Medical Device Regulations 4
D Distribution of a Kit composed of Piece Parts from several Manufacturers EU Medical Device Regulations 3
M Problems implementing ISO 13485 for Software-Only Medical Device Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 4
E FDA Quality Systems and DAMAS (Dental Appliance Manufacturers Audit Scheme) US Food and Drug Administration (FDA) 3

Similar threads

Top Bottom