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

Super Moderator
#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
C Product compliance process REACH and RoHS Conversations 5
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
V Countries without Formal Regulatory Approval Process Other Medical Device Regulations World-Wide 0
J Crimp inspection and process verification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Crimpshrine13 Bulk Process (Electroplating), Control Plan, and Process Change IATF 16949 - Automotive Quality Systems Standard 0
S Process Owner IATF 16949 - Automotive Quality Systems Standard 10
Bev D Development Process: FMEA, Critical Characteristics, Spec Setting and Controls Misc. Quality Assurance and Business Systems Related Topics 0
T Document Review Process Map AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Validation Plastic Injection Molding Process protocol ISO 13485:2016 - Medical Device Quality Management Systems 5
M Use of statistical techniques for Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 9
A Question regarding new VDA_AIAG fmea approach for process FMEA FMEA and Control Plans 0
S 9001 + 14001 Internal Auditing Process checklist, flowchart or questionnaire ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L CQI-30 Special Process: Rubber Processing System Assessment - Mixing & Molding IATF 16949 - Automotive Quality Systems Standard 4
O Process Flow Diagram, DFMEA, PFMEA, Control Plan integrated softwares FMEA and Control Plans 4
C. Tejeda Process validation of rework assembly methods (medical devices) Medical Device and FDA Regulations and Standards News 3
L Looking for feedback on Nonconformity Process Flowmap ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Process Flow of ECN Product User and Service Guides Process Maps, Process Mapping and Turtle Diagrams 1
R Process Maps for ISO 17025 ISO 17025 related Discussions 2
L APQP Process Flow with CFT Roles and responsibilities APQP and PPAP 4
M Having Trouble Identifying KPI for Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Please help! ! I AM FRASTRATED SO MUCH! Should inactive ingredient be included in the unit formula if it is removed during the manufacturing process? US Food and Drug Administration (FDA) 0
I Supplier Evaluation Process ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom