الوصف

Medical device regulations are constantly changing and evolving to better safeguard the health and safety of the public. However these regular changes may impact manufacturers with regards to their product requirements and registrations with local and overseas regulators.

At STC, our team of knowledgeable experts are up-to-date with the latest regulatory requirements in key markets to ensure that compliance is met and support medical device manufacturers in gaining market entry quickly.


Key Market Support:

• Australia (DOH)
• Brazil (MOH)
• Canada (HC)
• China (CFDA)
• Europe (CE Notified Body MDD / MDR)
• India (MOH)
• Japan (MHLW)
• Korea (MFDS)
• Malaysia (MOH)
• Singapore (HSA)
• Taiwan (TFDA)
• United States (FDA)
•  

Our Medical Device Product Classification & Regulatory Support services include:

• Document Preparation for ISO****5 Certification (Gap Analysis)
• Medical Grade Components Sourcing
• Technical File / Dossier Compiling
• Collateral, Particular Harmonized & Industrial Standards Testing
• Test Equipment Setup for Performance Testing
• Biological Testing according to GLP Requirements
• Submission of Technical File to Regulators
• Representation by Local Representatives 
• License Holding & Risk Management
• On-site Support during Regulator Inspections
• QMS/QSR support on CFR**0, ISO****5, Canada MDR, Korea GMP, Brazil GMP and Japan Ordinance **9
•  

Electrical Testing

• ISO ****5
• CB Scheme
• NRTL Program.

Biological Testing (ISO ****3)

• Interactions with blood (ISO ******4)
• Vitro Cytotoxicity (ISO ******5)
• Local Effects after Implantation (ISO ******6)
• Ethylene oxide sterilization residuals (ISO ******7)
• Irritation (ISO *******0)
• Skin Sensitization (ISO *******0)
• Systemic Toxicity (ISO ****3 **1)

LUCIDEON Medical Device Services

• As part of our commitment to offering the most extensive services to our customers, STC is working in collaboration with LUCIDEON to provide a greater range of services including Medical Device Consultancy, Materials Developments and Technology Innovations.

If you have any further question, please feel free contact us.