SBS - The best value in QMS software

Process changes and biocompatibility (ISO 10993-1)

#1
It has been proposed to change the 2-dimensional shape of a class III bioabsorbable implant. There will only be one difference in the processing of the new implant versus the old one and that is that the material from which the cutting tool is made will change from Stainless Steel (D2) to Stainless Steel (410). The implant is in contact with the cutting edge for a matter of seconds. Based on a literature review the 400 series SS is frequently used in the manufacture of surgical drilling and cutting tools. The same cleaning materials would be used so there would be no risk of new residues from processing aids being introduced.

Given cost and time restraints, I'd like to get this communities thoughts on the following options for submission of the change notification to both US and EU regulators (under MDR)
  • Would the above justification be sufficient to address this change i.e. that the change does not introduce any new risks from a biocompatibility perspective because i) there is no change to the processing aids used ii) though the SS used is of a different grade, the grade used is in contact with the implant very briefly and iii) the 400 series SS is frequently used in the manufacture of surgical instruments e.g. dental drills? Based on this justification, it would be reasonable to say that no additional biocompatibility testing is required and the biocompatibility data from the original implant is sufficient to demonstrate the biological safety of the new implant?
  • Would additional biocompatibility testing have to be performed to justify this process change and if so, what testing would be recommended?
 
Elsmar Forum Sponsor

planB

Trusted Information Resource
#2
Lorna,

some considerations:

1) A change notification (CN) and/or submission implies that your internal change management process came to the conclusion that changing the steel material in a manufacturing equipment is _significant_.

However, your evaluation seems concludes that you have enough data at hand to demonstrate equivalence of the two steel materials without additional testing. This would provide you with an argument to justify that this change is actually _not_ significant_ and thus, does not require a CN or submission.

2) In case you come to the conclusion of additional testing, you might evaluate the potential impact of the material change ion cutting tool: Assuming that both the existing and candidate cutting tool are equally free of organic residues and particles, you might only analytically investigate potential inorganic extractables via ICP: to this end, you can either extract the candidate tool itself (worst case) or a product representative manufactured with the candidate tool. In case you detect equivalent levels of inorganics in the extracts, you could support your initial conclusion that the steel material change does not adversely affect biocompatibility of your existing product.

HTH,
 
Thread starter Similar threads Forum Replies Date
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
S Qualification Builds & Process Changes (AS9102 - First Article Inspection) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
O PFMEA - Reducing Severity (S) Ranking - Manufacturing Process Design Changes FMEA and Control Plans 4
A Process Changes, but Work Instructions/Process Maps are not updated ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q Form for Managing Coating Process Parameter Changes during Production Document Control Systems, Procedures, Forms and Templates 2
J Process Changes - Customer Notification Requirements APQP and PPAP 12
R Verification of Process Changes (AS9100 clause 7.5.1.2) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
AnaMariaVR2 FDA, Suppliers, & Process Changes [article] Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M AS 9100 4.2.4 Process for making changes to records is not fully effective Quality Manager and Management Related Issues 4
V ECR/DCR Process Flow - What changes require an ECR vs. a DCR Document Control Systems, Procedures, Forms and Templates 2
L Changes to Manufacturing Process or Device with CE Marking CE Marking (Conformité Européene) / CB Scheme 2
M Changes Assessment as per AS9100 Clause 7.5.1.2 Control of Production Process Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T How to link Process Design Changes in Serial Production to Design & Development? Design and Development of Products and Processes 6
M Document Changes not affecting the process - Adding Logos, etc. Document Control Systems, Procedures, Forms and Templates 8
5 Changes to Control Plans or PFMEA's (Process FMEA) FMEA and Control Plans 6
M Process changes related to Components APQP and PPAP 4
R Informing Customers of Process Changes - Is this considered a process change? Manufacturing and Related Processes 19
R Preventative Action - Organizational ideas - Process or Work Instruction Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S PPAP for my tier 3 suppliers - Sub-Supplier Process Changes APQP and PPAP 16
M Looking for Best Way to Communicate Process Changes to Production Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Defining Process Changes and Customer Notification Requirements IATF 16949 - Automotive Quality Systems Standard 33
R Manufacturing Process Changes (7.1.4) IATF 16949 - Automotive Quality Systems Standard 3
J Process Control / Changes QS-9000 - American Automotive Manufacturers Standard 13
M Process changes QS-9000 - American Automotive Manufacturers Standard 5
K APQP - Is the APQP process supposed to include process changes? APQP and PPAP 2
B Toyota PPAP Process - Three Questions APQP and PPAP 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
V Laser Welding Process - Impact on Electrical Properties Reliability Analysis - Predictions, Testing and Standards 4
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
C In-process inspection - Tooling and assembly lines for automotive companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Efficacy of an IT process after a cyber attack ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
N Riveting - special process Manufacturing and Related Processes 11
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 9
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 15
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
D Measurables for Plastic Injection molding process Manufacturing and Related Processes 1
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
R Inspection and Work order process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to reduce the process SPC monitoring Capability, Accuracy and Stability - Processes, Machines, etc. 3
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6

Similar threads

Top Bottom