How to find a medical device contract manufacturer, MDSAP certified?

MedicalDevicesCanada

Starting to get Involved
#1
What are the ways to find a MDSAP certified medical device contract manufacturer?

Are there public databases or lists of the certified contract manufacturers that we could search through?

We are looking for a contract manufacturer that has a current MDSAP certificate to manufacture a new Class 2 product.

Thanks!
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#2
MDSAP is primarily for companies that have their own licenses.
Typically contract manufacturers do not have MDSAP since they are license holders.
 

MedicalDevicesCanada

Starting to get Involved
#3
Yes, I know and understand that.

Our idea is to manufacture new Class 2 device for Canadian market. We do not have MDSAP as our business is mostly in the regulatory consulting area.

Therefore the idea is to find a manufacturer who could make and own that device for us. I hope it is possible to find a company MDSAP certified that would be interested to manufacture a device as per our requirements.
 

DannyK

Trusted Information Resource
#4
Many contract manufacturers do not want the extra liability of having their name on a product.
It is easier to find a distributor that already has MDSAP that will buy your product and sell to the Canadian market.
I work with several of these companies and would be glad to put you in touch.
Please send me a private message with details about the device and the classification.
 
Thread starter Similar threads Forum Replies Date
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
L Find Local Authorized Representative (LAR) for medical device EU Medical Device Regulations 5
A How can I find out if a medical device is prescription only? Other US Medical Device Regulations 4
C How to find the Medical Device Listing Number (MDL Number) from the FDA website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D Where to find the Medical Device Classification Database ISO 13485:2016 - Medical Device Quality Management Systems 11
R How to find out the UMDNS code for medical devices CE Marking (Conformité Européene) / CB Scheme 1
V Where do I find Adverse Event Database for Medical Devices? Quality Manager and Management Related Issues 2
D UL Listing - Do you find UL Listing necessary? Medical Devices Other US Medical Device Regulations 11
M Where to find Medical Software Products on the internet? Software Quality Assurance 3
T ANOVA analysis to find F test. Using Minitab Software 3
I How to find required testing for a specific device? Other US Medical Device Regulations 3
N How to find column number for the last non-empty column? Using Minitab Software 0
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 2
M Find updates to REACH and Rohs regulations REACH and RoHS Conversations 1
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
S How to find technical specification for facilities maintainance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Where can I find examples of PPAP? APQP and PPAP 6
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
G Where to find Proficiency Test provider for photometrics (spectral %R, %T, photo density) General Measurement Device and Calibration Topics 9
C TL-9000 Certifying Body Issue - Auditor failed to find an issue for 10 years TL 9000 Telecommunications Standard and QuEST 16
M Plating standards - Where to find information AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
Proud Liberal DFMEA / PFMEA linkage - Where in the standards do I find it? FMEA and Control Plans 5
N Where I can find an Excel sample/template for recording Delivery Time and Cost Excel .xls Spreadsheet Templates and Tools 2
R Specification on flare testing extruded aluminum - Where to find Design and Development of Products and Processes 1
A AS9100 Rev:D in Spanish - where can I find a Spanish version? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
I Moving into Clinical Trials and need to find GMP Suppliers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
S Where to Find DEV and DFE numbers on FDA Website Other Medical Device and Orthopedic Related Topics 3
P Calibration in the UK to ISO 17025..cant find anyone ISO 17025 related Discussions 8
N Where to find a Qualified FDA Supplier Auditor located in China China Medical Device Regulations 7
G Where I could find any project HSE plan templates Occupational Health & Safety Management Standards 4
A Where to find a Draft Copy of IATF 16949:2016? IATF 16949 - Automotive Quality Systems Standard 23
M How to find the number of required data - Correlation with 4 variables Using Minitab Software 2
I Where to find VDA 6.3 Robust Production Process (rpp) PDF file ? VDA Standards - Germany's Automotive Standards 1
P Where to find the UMDNS code for CE Mark CE Marking (Conformité Européene) / CB Scheme 1
I Non-functional Corrective Action - Could Not Find some Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
P Where to find conformance statistics for ISO 15189 Other Medical Device Regulations World-Wide 1
J Where can I find a product's CE Mark Number? CE Marking (Conformité Européene) / CB Scheme 20
H How to find a good ISO 9001 Implementation Consultant in Calgary, Canada? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 6
R Where to find 21 CFR Part 820 Translated into Czech, Spanish, and German 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Where can I find the NADCAP Audit Criteria for all the processes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Where to find ISO27000 Annex A? General Auditing Discussions 2
W Where to find the Daimler DBL 6992 10 new (old) standard Customer and Company Specific Requirements 1
V Where I can find an AAR form on Ford Covisint? APQP and PPAP 1
L Find the right Test to fail method according to the standards of LV 124 FMEA and Control Plans 1
G Where to find the ANSI Z1.9 Rosetta Stone Capability, Accuracy and Stability - Processes, Machines, etc. 9
M How to find a Good Registrar (Certification Body) for ISO TS 16949 certification Registrars and Notified Bodies 3

Similar threads

Top Bottom