Medical Implant Sterile Packaging Design

S

SRavi

#1
Hello Friends,

I am a medical engineer and for our implantable medical device I am looking for a OEM company who can help us design final packaging. The packaging of this implant is to be sterilized by Eto. I would really appreciate if people here can point out to the companies who design such packaging on request.

I am open to companies all over the world but it would be great if the company is based in Central Europe as we are based in Germany.

Any help is appreciated.

Thank you.
 
Elsmar Forum Sponsor
G

Gert Sorensen

#2
I believe that you may be able to get some help with this issue by contacting Sterigenics, they do a lot of sterilization work and sterility testing, so they should be qualified. (I am not affiliated).

:bigwave:
 
S

SRavi

#3
Hello Gert,

Thank you for the prompt reply. I will get in touch with them. Please suggest some other firms also. I think the more the better option I can have.

:thanx:
 
G

Gert Sorensen

#4
You may also want to contact producers of sterile packaging, the only one I can think of at the top of my head is Tyvec, but I am sure that there are others too :) They also have a lot of knowledge about this.

Btw: Don't forget to validate your packaging - incl. transportation.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Hello Friends,

I am a medical engineer and for our implantable medical device I am looking for a OEM company who can help us design final packaging. The packaging of this implant is to be sterilized by Eto. I would really appreciate if people here can point out to the companies who design such packaging on request.

I am open to companies all over the world but it would be great if the company is based in Central Europe as we are based in Germany.

Any help is appreciated.

Thank you.
http://www.sealedairmedical.com/EU/EN/Nelipak/overview.aspx
 
Thread starter Similar threads Forum Replies Date
S Retained samples from each batch of spinal implant medical screws that we make ISO 13485:2016 - Medical Device Quality Management Systems 7
M Informational TGA – Medical device patient information leaflets and implant cards Medical Device and FDA Regulations and Standards News 0
S Do subjects pay for a medical implant in PMCF study? Quality Manager and Management Related Issues 3
D Device that makes another Device (Active Implant Medical Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D Medical Device Implant Registration Cards required by SOR/98-282 Canada Medical Device Regulations 2
D Declaration of Conformity for a Class III Medical Device Implant EU Medical Device Regulations 5
D Implantable Medical Device (Silicone Implant) Regulations for Thailand & Mexico Other Medical Device Regulations World-Wide 13
C Is a Test or Prototype Implant a Medical Device per ISO 13485 definition? ISO 13485:2016 - Medical Device Quality Management Systems 4
N New Medical Device - Ortho Implant ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 6
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 3
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 0
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 1
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
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
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5

Similar threads

Top Bottom