Regulations change regularly and these changes may have impact on your product registration with local and overseas regulators.
We have a team of experts to support medical device manufacturers to gain quick market entry and continue to comply with the latest regulation in Key Markets.
STC can provide full regulatory affairs support from product classification - Gap Analysis to preparing documents for ISO13485 Certification - sourcing medical grade components - compile Technical File/Dossier - testing according to applicable collateral, particular harmonized and/or industrial standards - set up test equipment for performance testing - Biological Testing to GLP requirements - Submission of Technical File to regulators - Local representative - License holding - Risk Management - On-site support on regulator inspection.
GLP biological testing facility located in Dongguan support ISO10993 testing under Regulatory Requirements.
Test includes :
- Test for interactions with blood [ISO10993-4]
- Vitro Cytotoxicity [ISO 10993-5]
- Local Effects after Implantation [ISO 10993-6]
- Ethylene oxide sterilization residuals [ISO10993-7]
- Irritation [ISO 10993-10]
- Skin Sensitization [ISO 10993-10]
- Systemic Toxicity [ISO10993-11]
Testing support according to IEC60601 series standards including EMC, Electrical Safety, Performance ISO10993 and testing according to specific product under Regulatory Requirements.
QMS/QSR support on CFR820, ISO13485, Canada MDR, Korea GMP, Brazil GMP, Japan Ordinance 169
Key Markets we support: US FDA, Canada HC, CE Notified Body MDD, China CFDA, Taiwan TFDA, Korea MFDS, Japan MHLW, Malaysia MOH, Singapore HSA, India MOH, Australia DOH, and Brazil MOH.
Lucideon Medical Device Services
As part of our commitment to offer the most extensive services to our customers STC has extended its collaboration with Lucideon (UK) to include Medical Device Consultancy, Materials Developments and Technology Innovations in the services that we are able to jointly provide. Lucideon are now also able to offer the testing and product registration services of STC.
Lucideon’s materials and technology expertise for the healthcare sector can be utilised to advance your products quickly and accelerate your growth in a competitive market sector.
To find out more about the services that STC can offer via Lucideon please visit:
www.lucideon.com/industries/healthcare/medical-devices (English) www.lucideon.com/industries/healthcare/medical-devices/medical-device-page-for-chinese-translation (Chinese)
Please feel free to download the brochures – English version / Chinese version.
