INSPECTION RANGE

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

     following :

     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

       c)  GMP

6 - LOADING SUPERVISION

-      Verification of final product prior to shipment for the following

       a)  Product

       b)  Size

       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

 
 
 
 
 
 

2018 by Business Solutios. Proudly created with MPSI IT Department

LOCATED AT

Lot 2-42, Jalan Meadow, Tiara Melaka Golf & Country Club, 

75450 Ayer Keroh, Melaka, Malaysia

CONTACT NUMBER

T: +6016-790 5828

F: +6 06-240 4046

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