SBS - The best value in QMS software

Approving a Test House on a Medical Device as a part of a 510k Submission

JoCam

Trusted Information Resource
#1
Hi All,

To enable laboratories at a University, which are neither accredited or certified, to perform a study on a medical device as a part of a 510k submission, how would I go about approving them for use to satisfy the FDA?

Your assitance with this will be very much appreciated.

Jo
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
There's no requirement for accreditation or certification as long as the tasks are done in accordance with the regulations.

They will be like any other service provider. You have to qualify them to perform the indicated activities. You have to ensure they have the equipment, training, ability, etc. to perform the tasks per the regulations. Thus, you have to know what that means. Applicable regulations may include 21CFR820 (QSR), 21CFR58 (GLP), 21CFR11 (ER/ES), etc. There may be others like HIPAA that need to be considered.

You'll need to assess the University to ensure that they can comply, documenting the approval just like any other supplier.

Side note: while not explicitly indicated by regulation, you'll want to be sure they follow Good Documentation Practices.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
There's no requirement for accreditation or certification as long as the tasks are done in accordance with the regulations.

They will be like any other service provider. You have to qualify them to perform the indicated activities. You have to ensure they have the equipment, training, ability, etc. to perform the tasks per the regulations. Thus, you have to know what that means. Applicable regulations may include 21CFR820 (QSR), 21CFR58 (GLP), 21CFR11 (ER/ES), etc. There may be others like HIPAA that need to be considered.

You'll need to assess the University to ensure that they can comply, documenting the approval just like any other supplier.

Side note: while not explicitly indicated by regulation, you'll want to be sure they follow Good Documentation Practices.
I generally agree though I would use "you have to" a bit less, and instead use "you better". The only thing you "have to" is follow your own procedures and requirements on suppliers selection and approval (assuming they comply with part 820's Purchasing Controls). Using an external lab for bench studies that don't require certification is just like using your own R&D lab, for instance.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
C Approving AWS as a supplier (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 4
M Suitable form or questionnaire for approving consultants Document Control Systems, Procedures, Forms and Templates 9
N Understanding, Challenging & Approving Supplier Control Plans FMEA and Control Plans 7
R Question of Approving Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Approving Software Suppliers in an AS9100 Company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Approving a New Hand Assembly Line at a Supplier Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Approving Suppliers by "Grandfathering" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
N Role of Quality Function in Approving Work Instructions Document Control Systems, Procedures, Forms and Templates 4
Q AS9100 Clause 8.3 - Control of Nonconforming Product Process for Approving Personnel AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Approving Consulting Firms in a Medical Device Company ISO 13485:2016 - Medical Device Quality Management Systems 25
T Approving Suppliers - Approving Marketing Companies Other ISO and International Standards and European Regulations 10
P Originating and Approving Internal Procedures Document Control Systems, Procedures, Forms and Templates 9
L Approving myself as a Supplier - Should we be on our own ASL AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M Gage R&R for Big Parts - Approving a Variable Gage using only 1 Part Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
G Does AS9100 require approving your Customer as a Supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Re-approving documents when the responsible person leaves or changes responsibilities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Qualifying and Approving Equipment for Welding AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Process for Approving Personnel Making Decisions - AS9100 Clause 8.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
B Approving Suppliers - Consultants AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Approving Suppliers under 7.4.1 - Approved Suppliers List - ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Approving Suppliers under 7.4.1 - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
Anerol C Who is Approving your Manufacturing Visual Aids / Process Sheets? Document Control Systems, Procedures, Forms and Templates 6
T Approving documents prior to issue - What guarantees their adequacy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
E Tensile test machine, tinius olsen 602 Manufacturing and Related Processes 1
M Test failure Root cause not found Customer Complaints 10
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Tip test 10° -> 5° IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Sponsor name presented in the test report EU Medical Device Regulations 4
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Disaster Recovery Test IT (Information Technology) Service Management 3
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
H Secondary Circuits, Voltage Test and Clearance/Creepage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Fogging test as per DIN 75201(50ug/g ) VDA Standards - Germany's Automotive Standards 3

Similar threads

Top Bottom