SBS - The best value in QMS software

Referencing Medical Device in FDA records - Package contains several other components

J

Jnks_Meddev

#1
#1
Hi Everyone,

I just came across this information and I am trying to find if there is any FDA guidance that explains this concept?

so my current company is selling a class IIa device in package form, the package contains several other components that are manufactured by our clients.

Our client can send their device for approval and reference our FDA approved device for further information to get the entire package approved. Can someone explain me if this is possible and what regulation/guidance provides more details on this.

Thank you!
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
A

Al Rosen

Staff member
Super Moderator
#2
#2
Jnks_Meddev said:
Hi Everyone,

I just came across this information and I am trying to find if there is any FDA guidance that explains this concept?

so my current company is selling a class IIa device in package form, the package contains several other components that are manufactured by our clients.

Our client can send their device for approval and reference our FDA approved device for further information to get the entire package approved. Can someone explain me if this is possible and what regulation/guidance provides more details on this.

Thank you!
Click to expand...
I don't know much about this, but I believe you can start here :Convenience Kits Interim Regulatory Guidance
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 4
M Referencing the MDR by name in QMS SOPs EU Medical Device Regulations 2
M Informational EC – Guide for referencing standards in public procurement in Europe (JIS Action 11) Medical Device and FDA Regulations and Standards News 0
N Referencing of a standard's year in routine regulatory compliance documents Other Medical Device Related Standards 3
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Referencing ISO 9001:2015 clause for Audit General Auditing Discussions 10
S Referencing International Standards as Design Input Design and Development of Products and Processes 5
D Referencing Standards in Procedures - Current version or actual? Document Control Systems, Procedures, Forms and Templates 6
S Referencing procedures on Control Plans - Best Practices FMEA and Control Plans 3
P Question on First Article Inspection referencing ISO 2768 APQP and PPAP 1
J Referencing the DMR (Design Master Record) in the PO Document Control Systems, Procedures, Forms and Templates 2
Q Referencing EN 63204:2006 instead of EN 62304:2006 AC:2008 IEC 62304 - Medical Device Software Life Cycle Processes 9
Q Referencing a Specification in a Work Instruction as a ?Guidance Document? ISO 13485:2016 - Medical Device Quality Management Systems 1
Crusader 7.6 Calibration (referencing outsourcing) in the Quality Manual Quality Management System (QMS) Manuals 5
M Referencing Standards in Engineering and Regulatory Documents Other ISO and International Standards and European Regulations 1
R Para 4.2.2 b) Referenced Documents - Adequate referencing? Copy and Paste? ISO 13485:2016 - Medical Device Quality Management Systems 5
S Referencing other documents in Control Plans Quality Manager and Management Related Issues 5
P Referencing of Forms in Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Referencing the Regulation in a Design Specification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Referencing or Using a Master Part to take Measurements Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Referencing and Controlling Labels & Stickers used internally throughout Production Document Control Systems, Procedures, Forms and Templates 1
Q AS9100 and NADCAP - Our QM was told that referencing IPC 620 was acceptable AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Referencing somebody else?s CE Mark and NB Number on an Instruction Leaflet? CE Marking (Conformité Européene) / CB Scheme 7
N Cross-Referencing ISO 9001/ISO 14001/OHSAS 18001 Occupational Health & Safety Management Standards 17
K Question about referencing software - Database Records Document Control Systems, Procedures, Forms and Templates 11
L Surveillance Audit - NC for not referencing requirement of Cl 6.4 in audit plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Q Work instructions - Referencing other documents including procedures Document Control Systems, Procedures, Forms and Templates 18
A Calling / Referencing National Standards in Quality Manuals Quality Management System (QMS) Manuals 1
S Purchased Material Inspection in Medical Devices Elsmar Xenforo Forum Software Instructions and Help 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 0
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
M NICE Medical Technology Evaluation Programme - Recommendations Service Industry Specific Topics 0
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
B Specialized Medical Apparel Manufacturing and Related Processes 1

Similar threads

Top Bottom