SBS - The best value in QMS software

ISO 13485 scope (implantable) - Polymers for dental application

Daliane

Starting to get Involved
#1
Hi all
My client is a Virtual Manufacturer of a polymer that is used for dental application with 3D printing technology. The polymer is sold to dental labs to print temporary implants (use up to 1 year) and dental bridges.
They don't manufacture this polymer, but get the ready bottles with content from the OEM. The polymer itself is class I.

I need help to assess whether it falls under following requirement of ISO 13485 section "7.5.9.2 Particular requirements for implantable medical devices"?

Thanks!

Regards
Daliane
 
Elsmar Forum Sponsor

planB

Super Moderator
#4
I need help to assess whether it falls under following requirement of ISO 13485 section "7.5.9.2 Particular requirements for implantable medical devices"?
Daliane,

as @indubioush pointed out: if your device falls under the definition ISO 13485, section 3.6, then yes, section 7.5.9.2 also applies to your device.

Hope this helps,
 

Daliane

Starting to get Involved
#5
Ok maybe I should clarify my question: I need help to determine if this resin is applicable to the definition in section 3.6
We declare that this resins can print dental bridges. But we don't sell the dental application, only the resins itself.

Any idea someone?


Thanks a lot!
 

somashekar

Staff member
Super Moderator
#6
Ok maybe I should clarify my question: I need help to determine if this resin is applicable to the definition in section 3.6
We declare that this resins can print dental bridges. But we don't sell the dental application, only the resins itself.

Any idea someone?


Thanks a lot!
NO. It does not.
7.5.9.2 can be your non-application
Your product / service is far from being what is said in 3.6 of terms and definitions.
 

monoj mon

Quite Involved in Discussions
#7
Although it looks like the resin doesn't fall under the section 3.6, but I feel like it is not that simple. As @Daliane has said and I quote
The polymer is sold to dental labs to print temporary implants (use up to 1 year) and dental bridges.
It is already intended as dental implant, the only difference is the user (dental lab) needs to give it a shape using a 3D Printer! What about "Bone Cement"! Are the ingredients considered to be under Section 3.6! Does anyone has any experience with it! I am just curious.
 
Last edited:

planB

Super Moderator
#8
Daliane,

you originally stated that your resin is a class I medical device. I assume you have an associated biocompatibility report on file? If yes, how did you categorize your device from an ISO 10993-1 perspective in terms of nature and duration of body exposure?
 

QM_123

Starting to get Involved
#9
Daliane,

Yes it is dental resin, you sell it to labs and they use 3D printers to make a final device (dental bridge). I think this is Class IIa device. Most probably you identified intended use as "dental bridge" in IFU . As planB said, you check your device category in terms of biocompatibility. On the other hand, I suggest you to check any equivalent device's IFU, if you are not sure. In this scope, I think 7.5.9.2 is applicable for your device. Your processes to produce your resin is important for safety and performance of the final device (dental bridges). For example, if you use wrong raw material or wrong mixture rates for resin that may cause non-biocompatible device.
 
Thread starter Similar threads Forum Replies Date
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
R Scope of ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 6
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
K MDSAP scope vs ISO 13485 Scope Canada Medical Device Regulations 4
R Scope of Certification for a Design Organization with Outsourced Mfg. - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
M OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope ISO 13485:2016 - Medical Device Quality Management Systems 4
chris1price What are the Scope Numbers on ISO 13485 Certificates ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO 13485 Certificate Scope modified by Notified Body EU Medical Device Regulations 9
S What is the scope of EN ISO 13485 and ISO 13485 ? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Scope of ISO 13485 Registration and Component Makers ISO 13485:2016 - Medical Device Quality Management Systems 7
D Scope of ISO 13485 Certification needs the word Production. ISO 13485:2016 - Medical Device Quality Management Systems 9
V ISO 13485 certification scope in Spanish ISO 13485:2016 - Medical Device Quality Management Systems 5
N Scope of ISO 13485 Certificate for Multiple Devices EU Medical Device Regulations 3
B Class IIb Medical Device using Annex II route - Need to Update ISO 13485 Scope? ISO 13485:2016 - Medical Device Quality Management Systems 2
L Non-medical device is in the ISO 13485 audit scope? ISO 13485:2016 - Medical Device Quality Management Systems 11
Ajit Basrur Scope for ISO 13485 vs. ISO 15378 - Molding Parts for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom