Medical Device Internal Test Certificate Example

Q

QACen

#1
Hello,

We manufacture medical devices and a customer is requesting for documentation of the results of our internal testing prior to shipment. I assume that this would be a test certificate or test confirmation type of document. Can anyone share a template?

Thanks!
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
What do you use in-house to document in-house testing such as final acceptance testing?
 
Q

QACen

#3
Yes. I know I can use information from those documents to summarize for the customer. I was just curious to understand what experienced folks in the industry do for the customer. What goes in that document? What are some things that should be listed? The customer was not specific.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
I'm not aware of any specific document, but then again - Every company and every product would be different. If you do final acceptance testing I would think that a copy of that report would be sufficient.

You will find a lot of folks here in posts like this will also say you should ask your customer directly specifically what they want. Their generically asking for something like "...documentation of the results of your internal testing prior to shipment..." would be to me final acceptance testing. Ask them if that is what they want, and if they're "not sure" or something like that, offer them a copy of your final acceptance test report(s).
 
P

Pelau

#5
Actually, they want a certificate of conformance - with the proof with the measurements and the method of testing. Concurs with other comments
 

SteveK

Trusted Information Resource
#6
Attached is the type of template I use for our customers, when requested. It shows an example of a particular standard (in addition to QMS references) the item complies with and was tested to, as per details in the Technical File.

This format has been accepted over many years in our case thus far.

Hopefully this helps.

Steve
 

Attachments

yodon

Staff member
Super Moderator
#7
I'm curious why such a cert would be necessary. As a medical device, it's in a regulated industry and the regulations require that the production be performed in a manner that (reasonably) ensures the product made will comply with its specifications.

I guess if it makes the sale, it's worth it but would customer education be possible?
 
P

Pelau

#8
In addition to the cert...the proof of the actual specifications were achieved and the inspection or tests carried out.
 
Thread starter Similar threads Forum Replies Date
Q Need Outsourced ISO 13485/FDA Internal Auditor for a Medical Device Company Internal Auditing 3
M Use of an Internal Powerstrip in a Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Internal Audit Process for small Medical Device company Internal Auditing 9
H Internal Auditing Frequency Requirements in a Medical Device Company ISO 13485:2016 - Medical Device Quality Management Systems 14
S Internal Files for Medical Device Ultrasound System Licence Other US Medical Device Regulations 6
V Biocompatibility of Medical Device Internal Parts Other US Medical Device Regulations 9
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
M Indian Medical Device Rules --Manufacturing and Whole sale Lic. Required ? Other Medical Device Regulations World-Wide 0
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
A Medical device Mode Of Action CE Marking (Conformité Européene) / CB Scheme 2
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 2
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 3
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 0
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 8
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3

Similar threads

Top Bottom