Demonstration of Equivalence - Need for comparing biological characteristics for an SamD

A

akp060

Involved In Discussions
#1
#1
I would like to know if a comparison of biological characteristics is required for the demonstration of equivalence in the context of Appendix A1 of MEDDEV 2.7/1 revision 4, when the Device under Evaluation is a SaMD (Software as a Medical device) device
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
planB

planB

Trusted Information Resource
#2
#2
Since MEDDEV 2.7/1 rev. 4 defines biological characteristics on p. 32 as:

Biological: Use the same materials or substances in contact with the same human tissues or body fluids.
Click to expand...
demonstration of biological equivalence is not applicable to your case. This is also in line with applicability of the ISO 10993 standard series, also mentioned on p. 32 in this context.

HTH,
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
TheMightyWife Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence EU Medical Device Regulations 6
M Exemption Clauses for Research, Demonstration, etc. Other Medical Device Regulations World-Wide 2
A Accelerated Reliability Demonstration Test Reliability Analysis - Predictions, Testing and Standards 4
B Israel Demonstration Medical Device Requirements Other Medical Device Regulations World-Wide 5
A Demonstration Test Plan for Reliability of Big Equipment Reliability Analysis - Predictions, Testing and Standards 5
R Exporting to Korea a demonstration only medical device Other Medical Device Regulations World-Wide 2
T "Time of Demonstration" requirement for Reliability Test Reliability Analysis - Predictions, Testing and Standards 1
T Reliability Lifetime Requirement Demonstration Test Reliability Analysis - Predictions, Testing and Standards 3
D Demonstration Reliability Test Formula with allowance for 'x' Failures Reliability Analysis - Predictions, Testing and Standards 6
W Medical Device Manufacturer Demonstration Equipment Other US Medical Device Regulations 6
D CE Marking for Demonstration / Evaluation Boards CE Marking (Conformité Européene) / CB Scheme 2
A Sale of Demonstration Units - How should we document it from GMP standpoint? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Howard Lee Electronic Approval Demonstration - Use of the voting option in Outlook Document Control Systems, Procedures, Forms and Templates 17
G Production rate demonstration? APQP Manual 4.1 ? Significant Production Run APQP and PPAP 7
J Best/Worst Production Demonstration Runs (PDR) - Share yours Manufacturing and Related Processes 3
B Demonstration of auditor competence. General Auditing Discussions 10
M Par.5.6.1 Demonstration of suitability, adequacy and effectiveness of QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Marc Demonstration Of Pavlov's Theory of Bureaucracy Philosophy, Gurus, Innovation and Evolution 1
D Proving Substantial Equivalence in Software Medical Devices Design and Development of Products and Processes 2
R Demonstrate how sufficient levels of access to data is achieved - Claims of equivalence EU Medical Device Regulations 3
K Substantial Equivalence Predicate Device Testing Other US Medical Device Regulations 1
H Claiming equivalence with the product that was sold earlier in the market but not now EU Medical Device Regulations 1
M Medical Device News FDA News - 14-09-18 - Benefit-Risk Factors to Consider for Substantial Equivalence Other US Medical Device Regulations 0
H Equivalence within Medical Device Family EU Medical Device Regulations 1
G HPLC Method Equivalence between USP and EP Various Other Specifications, Standards, and related Requirements 1
C Technical File Assessment from a NB - Clinical Equivalence CE Marking (Conformité Européene) / CB Scheme 6
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
P FDA - Evaluating Substantial Equivalence in Premarket Notifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
O Equivalence between AEC-Q200 and Product Life Time IATF 16949 - Automotive Quality Systems Standard 1
A Determination of Production Equivalence for Design Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T FDA 510k Submission - Section 012 SE (Substantial Equivalence) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G A question on Substantial Equivalence (SE) ? Other US Medical Device Regulations 1
P Testing a US device in Europe to prove Equivalence in a ?head-to-head? Study EU Medical Device Regulations 6
C Statistical Analysis to Demonstrate Substantial Equivalence to the FDA Other US Medical Device Regulations 5
I Determining Statistical Equivalence - Our Laboratory Results vs. our Suppliers Statistical Analysis Tools, Techniques and SPC 4
J The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Substantial Equivalence for Laser Wavelength - Class 2 Aesthetic Product Various Other Specifications, Standards, and related Requirements 2
C Equivalence Studies - Validation Activities for several Identical Pieces of Equipment Manufacturing and Related Processes 1
C Equivalence Studies - Validation Activities for several Identical Pieces of Equipment Qualification and Validation (including 21 CFR Part 11) 2
S New Equivalence Rules in Mexico for US and Canadian Medical Devices Other Medical Device Regulations World-Wide 9
C Clinical Data to Prove Equivalence Other US Medical Device Regulations 4
M Demonstrating Substantial Equivalence - Requesting 510(k) data from company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
A Process Standard deviations and equivalence of Cp & Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 3
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2

Similar threads

Top Bottom