Suppliers of ISO 10993 compliant Material for Skin Contact

S

SRavi

#1
Hello Friends,

I am a medical device engineer. I am currently looking for a ISO 10993 approved off the shelf material that fulfills all the test requirements to be used in skin contact for a longer duration. I think Neoprene and Polyisoprene are good options but I am not able to find any manufacturer. I do not want to conduct any required tests (or find some lab that would do it for me) to comply with ISO 10993 medical device standards. I would appreciate if you can suggest me any manufacturer who produce such medical grade neoprene/polyisoprene and whose certification I can use. If you have suggestions regarding any other material I can use, please feel free to suggest.

Any suggestion is welcome.

Kind regards,
Ravi :)
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
W ISO 10993 (Biological Evaluation of Medical Devices) for Suppliers Other ISO and International Standards and European Regulations 8
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6
G ISO 9001 8.4 applied to 7.1.3 - Suppliers of infrastructure requirements - IT and Print solutions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R ISO 9001 versus ISO 13485 for Suppliers to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Does our material suppliers’ supplier have to be at least ISO 9001 certified? IATF 16949 - Automotive Quality Systems Standard 3
O ISO 13485 for software company - Selecting suppliers ISO 13485:2016 - Medical Device Quality Management Systems 3
M Are Medical device Raw material suppliers required to be ISO 13485 certified ISO 13485:2016 - Medical Device Quality Management Systems 13
qualprod ISO 9001 - 9.3.2 c) 7 is answer for 8.4.1? Performance of external suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
F IATF 16949 - Cl. 8.4.2.3 - Which type of suppliers could be exempt of ISO 9001 IATF 16949 - Automotive Quality Systems Standard 16
A Does AS9100 require Suppliers to be Certified to ISO or AS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
B ISO 9001:2015 - 8.4 - 8.4.1 - Re-Evaluation of Suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M ISO 13485:2016 - IQ/OQ Requirements applicable to Electronic Component Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 4
I ISO 26262 standard may apply to automotive IC suppliers IATF 16949 - Automotive Quality Systems Standard 1
N Interesting Discussion How to Deal with Suppliers Who Refuse to Complete our ISO Survey? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 51
L Suppliers Problem - One of our material suppliers is not ISO certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Which large corporations require their suppliers to be ISO 9001 certified? Registrars and Notified Bodies 14
L Automotive Companies which require ISO 14001 certification of suppliers ISO 14001:2015 Specific Discussions 17
T How to manage Suppliers in accordance with ISO 13485 Requirements Supplier Quality Assurance and other Supplier Issues 5
P Approved Suppliers - ISO 13485 Normal Supplier Qualification Process Requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
C Minimum Requirements for Suppliers without ISO 9001 or TS 16949 IATF 16949 - Automotive Quality Systems Standard 8
E Notification To Vendors (Suppliers) of our ISO 9001 Registration Document Control Systems, Procedures, Forms and Templates 6
A Requirement for Accredited Suppliers - ISO 9001 Clause 7.4.1 Purchasing process Service Industry Specific Topics 4
R Consideration for Suppliers in ISO 9001 - Investigating customer complaints IATF 16949 - Automotive Quality Systems Standard 7
B Unregistered Bulk Scrap Metal Suppliers - Do they need to be ISO 9001 certified? IATF 16949 - Automotive Quality Systems Standard 10
R Periodic evaluation of suppliers - ISO 17025 4.6 Purchasing services and supplies ISO 17025 related Discussions 3
J Calibration Service Suppliers must be certified to ISO 9001? General Measurement Device and Calibration Topics 14
S Purchasing from non ISO 9001 certified suppliers through a certified one. IATF 16949 - Automotive Quality Systems Standard 4
J Why are John Deere suppliers required ISO/TS IATF 16949 - Automotive Quality Systems Standard 17
P What are ISO 14001 requirements for Sub-consultants, Contractors, Suppliers ISO 14001:2015 Specific Discussions 3
G Until where goes ISO TS 16949 for Suppliers ? IATF 16949 - Automotive Quality Systems Standard 1
H Medical Device Suppliers Becoming Certified to ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
P Certificate of Calibration Suppliers for an ISO 9001 company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D External Auditing of Critical Suppliers - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P List of ISO 17025 Approved Suppliers ISO 17025 related Discussions 10
J Approving Suppliers under 7.4.1 - Approved Suppliers List - ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Improving your suppliers to work according to ISO/TS IATF 16949 - Automotive Quality Systems Standard 3
C Is Renault expecting all suppliers test facilities to be ISO/IEC17025 ISO 17025 related Discussions 4
J ISO 17025 Accredited Suppliers from a QMI TS16949 Auditors Perspective? ISO 17025 related Discussions 2
S ISO/TS 16949 Registered with VDA 6.1 Compliant Suppliers IATF 16949 - Automotive Quality Systems Standard 8
G ISO/TS16949 - Fastener Supplier - Must my suppliers be TS 16949 registered? IATF 16949 - Automotive Quality Systems Standard 19
E Need an ISO 9001/14001/13485 Quality Manual - Many suppliers - Pharma and Med Devices Quality Management System (QMS) Manuals 7
M ISO 13485 - What requirements should I look for in my suppliers Supplier Quality Assurance and other Supplier Issues 1
M Suppliers - Certified or compliant to ISO/QS etc. Need letter example Supplier Quality Assurance and other Supplier Issues 2
S Non-ISO 9001 Suppliers - Customer approval letters to use Supplier Quality Assurance and other Supplier Issues 20
Q What to do with ISO 9001 registered Suppliers that have power? Supplier Quality Assurance and other Supplier Issues 6
D Supplier certification waiver format - ISO/TS16949:2002 Suppliers Supplier Quality Assurance and other Supplier Issues 16
T Is QS-9000 certification acceptable for suppliers or must they be ISO 9001:2000? Supplier Quality Assurance and other Supplier Issues 4
C Medical Device Component Suppliers - Require ISO 13485 system? ISO 13485:2016 - Medical Device Quality Management Systems 10
apestate Does TS 16949 require all suppliers (vendors) to be ISO 9001 registered? IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom