MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device

B

BBO

Registered
#1
#1
It's very normal case for in vitro diagnostic test kit to include lancing device.
In our case, lancing device included in our test kit which is OEM product.

I want to ask that OEM for lancing device needs to transition to MDSAP?
 
Paper to QMS ad
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
R Exporting to Canada and MDSAP Canada Medical Device Regulations 7
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDSAP and 13485:2016 gap analysis Quality Management System (QMS) Manuals 1
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
M MDR Impact on MDSAP Countries Other Medical Device Regulations World-Wide 16
Watchcat What's up with MDSAP lately? Medical Device and FDA Regulations and Standards News 2
R What happens during a Stage 1 MDSAP audit? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Comparison essential requirements EU compared to those of MDSAP countries Other Medical Device Regulations World-Wide 3
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
J MDSAP Companion and HC requirements Canada Medical Device Regulations 4
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 15
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 5
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
B MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record Other Medical Device Regulations World-Wide 3
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
W Informational MDSAP Substantial change / Change of notice forms Document Control Systems, Procedures, Forms and Templates 2
XRAY_3121 Informational MDSAP Audit Findings - Document change orders Other Medical Device Regulations World-Wide 12
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
M Medical Device News EU interesting developments – embracing MDSAP and UDI alignment Medical Device and FDA Regulations and Standards News 0
M Medical Device News MDSAP Stakeholder Day – December 5, 2018 presentations Medical Device and FDA Regulations and Standards News 0
Ajit Basrur MDSAP Presentations - Dec 5, 2018 - Stakeholders Other Medical Device Regulations World-Wide 0
JoshuaFroud FDA Form MDSAP AU F0029.1.004 - Help with Completion US Food and Drug Administration (FDA) 0
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Sidney Vianna Interesting Discussion Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate? Canada Medical Device Regulations 0
T MDSAP AO Cost ISO 13485:2016 - Medical Device Quality Management Systems 2
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2
S Initial Importer and ISO 13485 (MDSAP) - Will the US company be included? ISO 13485:2016 - Medical Device Quality Management Systems 1
S MDSAP Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
K MDSAP scope vs ISO 13485 Scope Canada Medical Device Regulations 4
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
D How will the new MDSAP requirements affect the MDEL? Canada Medical Device Regulations 1
B Our NB doesn't accept new clients for MDSAP Canada Medical Device Regulations 8
A MDSAP benefit for manufacturer of low-risk devices Canada Medical Device Regulations 3
R Impact of an MDSAP certificate with all countries coverage Other Medical Device Regulations World-Wide 8
A ISO-13485 7.1 - Preparing for our MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
M What is a reasonable MDSAP cost? ISO 13485:2016 - Medical Device Quality Management Systems 9
Edward Reesor Canadian News article on impact of MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 10
C Substantial Change in MDSAP Audit Other Medical Device Regulations World-Wide 1
S How can we demonstrate to MDSAP auditors that we have the requisite training ISO 13485:2016 - Medical Device Quality Management Systems 9
T MDSAP readiness - Selling clinical product IVDs into Canada Canada Medical Device Regulations 7
F MDSAP vs "Full" FDA Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Question about Australia - TGA and MDSAP - Technical file ISO 13485:2016 - Medical Device Quality Management Systems 3
S TGA regulations and ISO 13485:2016 gap analysis MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 2
S MDSAP cost per jurisdiction ISO 13485:2016 - Medical Device Quality Management Systems 11
S Marketing in one of the MDSAP countries ISO 13485:2016 - Medical Device Quality Management Systems 0
K MDSAP Stage 1 Guidance Documents ISO 13485:2016 - Medical Device Quality Management Systems 1
S Internal Audit Program under MDSAP and 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 10

Similar threads

Top Bottom