1 - THIRD PARTY INSPECTION ON PRE-SHIMENT GOODS
- All the Medical Devices shall be inspected in a clear, concise and professional manner.
- Need trusted independents’ inspection to ensure that both your legal obligation and standard requirement are meets in accordance to the
National or International Product Specification.
- Provide/Support with all the information on inspection results immediately to Customer to enable them make a quick decision on the final
product performance prior to shipping.
- We deliver a detailed, electronic report to all the Customer upon completion of the inspection.
- Consultation on preparation of documents for 510K Pre-Market Notification for Medical Devices prior to entering the US Markets.
- Consultation on preparation of documents for CE Mark Certification for Medical Devices
- Consultation on preparation of Product Technical File for Medical Device.
- Performing the process verification at Manufacturing facility upon requested by the Customer to determine the
a) Raw Material Receiving & Approval Process
b) Production Process
c) Maintenance Process
d) In-Process and Final Inspection Process
e) Corrective Action and Risk Control Process
f) Effectiveness on Implementation of Quality Management System (QMS).
- Product Conformity Assessment to ensure Design method for specific product meets the requirement of Technical
Regulation and standard set by the Regulatory Authority in the Importing Country or Customer.
5 - INTERNAL AUDIT AT FACILITY
- Performing the Internal Audit at specified interval base on Facility’s requirement for the following standard.
a) ISO 9001
b) ISO 13485
6 - LOADING SUPERVISION
- Verification of final product prior to shipment for the following
c) Quantity - Base on Purchase Order
d) Labelling - Lot Number, Size, Manufacturing and Expiry Date.
e) Container Condition - Cleanliness, Holes, Dent & etc.
f) Arrangement of final goods - Bags or Cartons inside container.
g) Container Sealing upon completion of Loading Process.
- Consultation on preparation of QMS documentation to obtain the Certificates.
a) Standard Operating Procedure
b) Work Instruction
c) Support Documents