Low intensity Pulsed Ultasound machine (LIPUS)

S

srinu

Starting to get Involved
Dear Friends,
Our company developed the Low intensity pulsed Ultrasound machine (LIPUS) for simulating the bone post surgery (Example after Knee replacement).
I would like to know about the safety tests list to get the market approval,any relavent person could have a look and suggest me the tests list,It's great help for me at this atage.

Thanks in advance.
Srinu.
 
Y

yodon

Leader
Super Moderator
I would recommend going to an accredited test shop. They will engage with you to just define the relevant tests.

A lot of this testing is very specialized and require competencies beyond what most companies have so unless you have all the test equipment and competencies, your best bet is probably getting the testing done at a lab, anyway.
 
S

srinu

Starting to get Involved
yodon said:
I would recommend going to an accredited test shop. They will engage with you to just define the relevant tests.

A lot of this testing is very specialized and require competencies beyond what most companies have so unless you have all the test equipment and competencies, your best bet is probably getting the testing done at a lab, anyway.
Click to expand...

Thanks for your guidence..
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Low RH Effect on Elastomeric + Polyester General Measurement Device and Calibration Topics 3
D Ultra low freezer thermometers, best practices? ISO 13485:2016 - Medical Device Quality Management Systems 8
R MSA on set of parts with low variation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 20
Z REACH compliance for low volume product REACH and RoHS Conversations 1
B Combat Low Part to Part Variation in GRR Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
L Requirements for Cables used for Low-Voltage DC Mains (12-36VDC) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
R DFMEA/PFMEA mitigation of high severity (9-10) in low volume products IATF 16949 - Automotive Quality Systems Standard 1
Proud Liberal Improving low p-value Statistical Analysis Tools, Techniques and SPC 13
D Importing a general wellness low risk product Other US Medical Device Regulations 3
CPhelan Best metrics for monitoring low volume (<1000) parts per vendors Supply Chain Security Management Systems 1
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 5
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
N Use part of high risk device for establishing low risk device EU Medical Device Regulations 0
R Laminate ESD Mats - Low resistance (RTT) readings Manufacturing and Related Processes 6
J Question on very low NDC number with tolerable GRR ratio's Capability, Accuracy and Stability - Processes, Machines, etc. 7
A MDSAP benefit for manufacturer of low-risk devices Canada Medical Device Regulations 3
Rincewind Clinical Evaluation of very low risk medical devices EU Medical Device Regulations 3
L Nonconformity's risk is too low, so don't report it? General Auditing Discussions 25
E Applicability of Low Voltage Directive (LVD) for 12V equipment CE Marking (Conformité Européene) / CB Scheme 4
M Testing a Low Current (Battery) DC Medical Device Other Medical Device Related Standards 4
M Battery Powered Measurement Equipment and Low Voltage Directive CE Marking (Conformité Européene) / CB Scheme 1
G CE Marking - Low Voltage Directive and EMC Directive CE Marking (Conformité Européene) / CB Scheme 4
Marc New FDA guidance on low-risk wellness devices US Food and Drug Administration (FDA) 1
J If/how to apply LVD (Low Voltage Directive) in this case CE Marking (Conformité Européene) / CB Scheme 6
R Looking for good, low cost APQP Software recommendations APQP and PPAP 2
V For screening a design, can we live with the low/poor predicted R-Sq.? Statistical Analysis Tools, Techniques and SPC 3
M Chrysler PSW Sign Off when your product is rated low risk in CQMS IATF 16949 - Automotive Quality Systems Standard 5
S Low Sample Size for Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M David vs Goliath (Large Suppliers vs Low Volume Purchasers) Supplier Quality Assurance and other Supplier Issues 11
C Hardness Testing - Low Cpk's using Minitab Misc. Quality Assurance and Business Systems Related Topics 10
Wes Bucey A "Feel Good" story - 3D Printing Creates Low-Cost Prosthetic Fingers Coffee Break and Water Cooler Discussions 0
B Determing Machine Capability in a High Mix, Low Volume Sheet Metal Shop Manufacturing and Related Processes 4
Y How to cut off Extremely High and Low Data Statistical Analysis Tools, Techniques and SPC 2
S How to Capture Low Volume Process Info? Lean in Manufacturing and Service Industries 3
M Control Measures for Hazards already deemed Low Risk ISO 14971 - Medical Device Risk Management 6
M Need Machining Low Volume Family Control Plan and PFMEA APQP and PPAP 1
C CE Marking for LVD (Low Voltage Directive) Health and Beauty Products CE Marking (Conformité Européene) / CB Scheme 5
C Suggestions on Sample Plans for High Volume/Low Cost/Low Risk Components Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
F CE Marked Motors - BS-EN61010 for the Low Voltage Directive CE Marking (Conformité Européene) / CB Scheme 1
S FMEA Manual aimed at Low Volume Fabrication Industry FMEA and Control Plans 1
B Understanding why my CpK and PpK are low, and LCL Statistical Analysis Tools, Techniques and SPC 20
N Extent of Product Traceability Required by ISO 13485 (Low Level Class I Devices) ISO 13485:2016 - Medical Device Quality Management Systems 3
J CAPA Effectiveness Checks on Low/No Volume Processes Nonconformance and Corrective Action 7
J How to determine a Capability Study for Low-Volume Suppliers Capability, Accuracy and Stability - Processes, Machines, etc. 3
J Use of PPMs in Low Volume Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G ISO 17664 Reusable Low Risk Medical Device Cleaning Other Medical Device Related Standards 2
M Differences between High, Medium, Low Risk Suppliers Supplier Quality Assurance and other Supplier Issues 5
K Probability of Occurrence Ranking for Low Volume Manufacturing vs High Volume FMEA and Control Plans 11

Similar threads

Top Bottom