SBS - The Best Value in QMS software

Help establishing regulatory requirements - Plastic dental cartridge syringe

#1
Dear all,

We manufacture a dental cartridge syringe which is single use and made of medical grade plastic. On looking at the regulatory requirements on the FDA website, I found that dental cartridge have a product code of EJI. The descriptions states the syringe has a metal body. Would we be able to use the same regulatory route given the different materials used? Also the metal syringe is reused while ours is single use.

The product is registered in the EU as a class 1 medical device (non-sterile and non-measuring). Bio compatibility and shelf life testing has been done.

Advice is appreciated. Also calling for any experts who can assist in obtaining FDA approvals.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
T Help establishing a good Customer Complaints Procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Need help establishing a DMR (Device Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Azaarus Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 9
A Help needed with locating conector Design and Development of Products and Processes 0
Y CER: can "state of the art" help to make up for literature search on equivalant devices? EU Medical Device Regulations 1
D Need some Help on 8D fault tree analysis Problem Solving, Root Cause Fault and Failure Analysis 6
B Can someone help me explain P-Value with a simple word please? Capability, Accuracy and Stability - Processes, Machines, etc. 11
M Help on formulating a LP minimization problem Manufacturing and Related Processes 2
N Help with understanding Process Controls Manufacturing and Related Processes 7
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
S Need help with analysing a survey on minitab Using Minitab Software 1
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
I Help: QFD House of Quality Quality Tools, Improvement and Analysis 1
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
M Thanks for the help Coffee Break and Water Cooler Discussions 0
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Burn out - Tips to help combat QC burnout Career and Occupation Discussions 19
Emran.mi Measurement system analysis - Can you help me about implementation MSA for CMM device Manufacturing and Related Processes 2
S New to FAIR, need help in filling it out AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
M Reliability Testing - Weibull Analysis Help Reliability Analysis - Predictions, Testing and Standards 4
L Help me to decide which test to use - If each proportion belongs to the same population Using Minitab Software 7
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1
R Pls help --- Need expert advice on Video Measurement Measurement Uncertainty (MU) 0

Similar threads

Top Bottom