SBS - The Best Value in QMS software

Virtual manufacturers/OEM - CE/ISO requirements

S

sara_jg

#1
Hi all,


we(as a virtual manufacturer) want to add few OEM products in our product list and sell those products in our name and also put CE marking.

The OEM already have CE. Can we put "manufactured by" our address and use their CE marking.

or

shall we get the technical file from OEM(they are ready to share the technical file accept few documents which they will share with EU representative directly)and go on registering the product with our EU representative(which we have for our own products) and put CE and our address as "manufactured by"..on the product.

Please give suggestions if the above process can be done.

and also what about ISO 13485, as a virtual manufacturers can we add these products in our scope? or have to do a audit at OEMs place?

Thank you in advance
Sara
 
Elsmar Forum Sponsor

htcoztrk

Starting to get Involved
#2
Hi Sara,

If you want to put your company name/trademark on product but use the CE marking of OEM that can we done. As you mentioned that OEM has already CE marking I assume the devices are above class I and requiring conformity assesment by notified body. In this case before putting the "manufactured by" on product the OEM company needs to make an scope extension application to his CE notified body and include your company name/trademark (in case the NB indicate it on certificate etc.) and product codes into their scope.
I'm not sure how what is the requirement on technical documentation but now upcoming MDR things will be tighter. So I would have asked full of their CE technical documentation and design dossies (if it is a class III) to keep in your hand in case of need in future. Also you should add a clause into your agreement that the OEM will provide full technical documentation, updated the documents in case of any revision and allow your company or regulatory authority to inspect their production plant. You can also check the MHRA's guadince on this published last year "Virtual Manufacturing replaces Own
Brand Labelling for medical device manufacturers Version 1.0 March 2017"

Regarding ISO 13485, yes you can add these products into scope. But as you are outsourcing the most of the product realization process such as production, design and process controls your certification body most probably needs to perform the audit at OEM's place. Also you should define in your QMS that how you evaluate the supplier, ensure the product conformance etc.
 
#3
Hi Sara,
Regarding ISO 13485, yes you can add these products into scope. But as you are outsourcing the most of the product realization process such as production, design and process controls your certification body most probably needs to perform the audit at OEM's place. Also you should define in your QMS that how you evaluate the supplier, ensure the product conformance etc.
I'd like to add that as per clause 4.1.5 of the ISO 13485:2016 you would need a detailed quality agreement with the manufacturer
 

Cali_Kitson

Starting to get Involved
#4
Hi All,

I have recently been assigned a project to implement ISO13485:2016 for our company. Our manufacturer have ISO13485:2016 accreditation however we wish to certify our own company as ISO13485:2016 compliant.

Currently we have a basic QMS and have 1 class I product.

This is my first experience of working with contract manufacturers and I would like to gain some clarity and understand from someone who has some experience in this area what is required of us in terms of procedures. If I take the requirements of clause 7.6, regarding measuring and monitoring equipment, for example, monitoring and measuring is performed by the CM, there is detail of this in the QTA, but would we be required to detail this in a procedure as part of our own QMS too?

We have a detailed QTA in place with the manufacturer.

I would appreciate if anyone could point me in the direction of some good guidance, or could provide some mentoring for a fair price.

Thanks,
 

yodon

Staff member
Super Moderator
#5
First off, you can't "certify [y]our company as ISO13485 compliant."

As the legal manufacturer (your name on the product), you're responsible for ensuring all regulatory aspects are fulfilled. You wouldn't detail what your CM does in your QMS.
 

Cali_Kitson

Starting to get Involved
#6
First off, you can't "certify [y]our company as ISO13485 compliant."

As the legal manufacturer (your name on the product), you're responsible for ensuring all regulatory aspects are fulfilled. You wouldn't detail what your CM does in your QMS.
Thanks Yodon. Ok, to word it better, at some point, we wish to become 13485 certified, for now, we are using a 13485 certified CM.

With respect to our own QMS, we have procedures for handling complaints, for CAPA, doc control etc. etc., however as we are not directly involved in the assembly of the device, we do not have procedures in place for equipment calibration, preventive maintenance etc. We have audited their QMS and are happy that all regulatory requirements with respect to the production are met, and this is all detailed within the quality agreement.

What I don't understand is how I would satisfy the clauses within the ISO 13485 standard where the activities are carried out by the CM. For example, as we have no equipment, are we able to omit these requirements from our own QMS, and note this in our QM? We have audited the CMs procedures which relate to equipment maintenance and are happy that they satisfy the requirements of the relevant clauses within the standard.

Forgive me but I am very new to working with contract manufacturers, and I am doing my best to develop an understanding of the requirements. I am also the only person with any understanding of quality or regulatory requirements within the start-up which is why I come here for support.

When I took the job, I was told the company had a well established QMS and I would be responsible for maintaining it, when I arrived, it turned out they had no QMS whatsoever and I had to implement from scratch. I think this would be a challenge for anyone, let alone a rookie with only a few years experience of working in medical devices (I used to work in Rx).

As mentioned, I am looking for some one on one consultation and would be willing to pay a fair hourly rate in order to gain some clarity in some areas where I am struggling.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
What I don't understand is how I would satisfy the clauses within the ISO 13485 standard where the activities are carried out by the CM.
The scope of ISO 13485:2016 has the following paragraph: "...The processes required by this international Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining and controlling the processes. .." So, you need to make sure that your QTA with the CM ensures that ALL of the APPLICABLE/RELEVANT requirements of ISO 13485 are addressed.

You mentioned that the CM is certified to ISO 13485, but we know that there are certificates that are earned and others that are bought. Is the certification body of your CM supplier trustworthy? properly accredited? Do you have access to the CB audit reports? Have you asked to see them? It might surprise you that certified organization have some significant QMS problems. Do you perform any assessment of the CM, yourself? A properly accredited certificate gives you a reasonable degree of confidence in the CM's degree of conformance with the 13485 standard, but, still be aware that your product line might never be audited by the CB auditor, especially, if it is a low volume production.

Not saying it is the case here, but, in many cases, start-up organizations that outsource the production processes don't have the financial resources to engage with well established (but pricey) CM's and make procurement decisions highly biased on price. Should I need to repeat the cliche caveat emptor? Suppliers, such as a CM are always, and simultaneously, an asset and a liability, and must be managed accordingly.

In answer to your specific question, you need to have a good process in place to screen/select your CM; you must have a thorough, well developed bespoke QTA with the CM; you must monitor the performance of the CM against the QTA and you must REACT when problems arise.

Good luck.
 

Cali_Kitson

Starting to get Involved
#8
Thanks Sidney.

The CM we have chosen were recommended by our design partner and are certainly not the cheapest. They are extremely cooperative, their documentation is of a very high standard and they have a good reputation. A bespoke QTA has been prepared, and we have had zero problems with any of their work. Unfortunately, after the past few months, I am well aware of the tendency of start-ups to do their best to avoid spending money!

My concern is more with my own ability, and a lack of internal support, to ensure there are no deficiencies within certain areas of our own documentation. This forum has been a massive help for me and I am extremely thankful to all of the members for providing valuable advice and content.

Thankfully, the product is a low risk class I device, manufactured in low volumes, and we are in no rush to apply for ISO 13485, so a couple more months of learning and we should be in a good place.
 
Thread starter Similar threads Forum Replies Date
S Distinction between a critical supplier and a Virtual manufacturer EU Medical Device Regulations 2
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 13
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 3
GStough WCQI Virtual Conference May 6, 2020 Coffee Break and Water Cooler Discussions 1
D Virtual Documentation via Master Flow Chart? Process Maps, Process Mapping and Turtle Diagrams 4
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
D Certifying a "virtual" company with zero employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
M Informational MHRA – Virtual manufacturing of medical devices – Updated guidance Medical Device and FDA Regulations and Standards News 1
dgrainger MHRA guidance on Virtual manufacturing - version 2 EU Medical Device Regulations 1
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
J Virtual Manufacturer and CE Marking EU Medical Device Regulations 8
M Virtual Manufacturer vs Reseller (Medical Devices) EU Medical Device Regulations 0
TheMightyWife Virtual Manufacturer v Medical Device File (NB audit) EU Medical Device Regulations 12
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
B Virtual Manufacturer / OBL ISO Requirements Other ISO and International Standards and European Regulations 3
M Audit Mandays for OBL/Virtual Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
W Virtual Manufacturer and Risk Management ISO 14971 - Medical Device Risk Management 3
I MHRA - Virtual Manufacturer Document Requirements EU Medical Device Regulations 2
K Quality Manual for a Virtual Company (Medical Device) Quality Management System (QMS) Manuals 2
P Qualification of pest control service in a "virtual manufacturer" ISO 13485:2016 - Medical Device Quality Management Systems 3
P How to add Voip features (ring group, virtual receptionist) into Cisco SIP PBX in C#? Medical Information Technology, Medical Software and Health Informatics 1
J FDA Compliant Quality System for Virtual Manufacturing (IVD Medical Device)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W ISO 13485 - The use of virtual offices (everything is sub-contracted) ISO 13485:2016 - Medical Device Quality Management Systems 4
MarilynJ6354 American Global Standards Virtual Registrar ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A American Global Standards Virtual Cert Program for ISO 9001 Registrars and Notified Bodies 12
M Environmental Protection Virtual Event - 2010 Miscellaneous Environmental Standards and EMS Related Discussions 0
Stijloor Virtual Reality Tour of the Basilica of Saint John Lateran Travel - Hotels, Motels, Planes and Trains 3
K Virtual DMIS vs. PC-DMIS - Help needed Calibration and Metrology Software and Hardware 3
Wes Bucey SAE Virtual Job Fair - May 19, 2010 Career and Occupation Discussions 2
Q ISO 13485 Design Control Procedure for Virtual Manufacturer wanted ISO 13485:2016 - Medical Device Quality Management Systems 8
kisxena Transferring a validated software platform to a virtual server Software Quality Assurance 8
V ISO 9001 Virtual Audits - Ways to audit remote locations such as design centers General Auditing Discussions 6
T CMM Reverse Engineering Scannning 3-D - IMS Impact with 4.8 version Virtual DMIS Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
RoxaneB Are You Interested in Coming for a Virtual Walk? Coffee Break and Water Cooler Discussions 130
I Virtual Manufacturing and ISO 13485 - Cardiovascular products ISO 13485:2016 - Medical Device Quality Management Systems 7
Govind Virtual Audit by Internet or Electronic Communication - Do you have any success? General Auditing Discussions 11
Marc Virtual Office and Multi-Site Registration: Including the FedEx Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 8
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 8
T Selection Of Contract Manufacturers Supplier Quality Assurance and other Supplier Issues 2
JoCam Registration of other manufacturers devices UK Medical Device Regulations 3
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
Nikki9154 MDSAP inquiry for China Contract Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 4
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 10

Similar threads

Top Bottom