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 ISO13485 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 CFR820, ISO13485, Canada MDR, Korea GMP, Brazil GMP and Japan Ordinance 169

 Electrical Testing

• ISO 17025
• CB Scheme
• NRTL Program.

Biological Testing (ISO 10993)

• Interactions with blood (ISO 10993-4)
• Vitro Cytotoxicity (ISO 10993-5)
• Local Effects after Implantation (ISO 10993-6)
• Ethylene oxide sterilization residuals (ISO 10993-7)
• Irritation (ISO 10993-10)
• Skin Sensitization (ISO 10993-10)
• Systemic Toxicity (ISO 10993 -11)

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 or visit our website: https://www.stc.group/en/contact