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Design & Development / Verification & Validation

Project Management

Dedicated team leads projects seamlessly through each phase. In every project we keep track of all milestones in a detailed way to ensure the timely delivery of a high quality product. We pride ourselves on our responsiveness and reliability, which makes us trusted partners to our customers. We seek to understand our customers’ needs so that we can find innovative solutions to accomplish their aspiration.

Design for Manufacturability and Assembly

Involve expertise from quality, regulatory, production engineering, manufacturing and sourcing since the beginning of the design phase, to optimize the selection of materials, components, assembly process and secondary process. All these are essential to ensure products are designed and developed in cost competitive and in the shortest lead time with the highest consistent quality possible.

Design for Packaging
  • Design packaging for Low Cost, Good Presentation (Appearance) & Durability.
  • Design packaging for compliance with international packaging standards.
  • Design packaging for regulatory requirements
Design for Sterilization
  • Design for In-house or outsourced sterilization
  • Design protocol for specific products
  • Validation for protocol
  • Validation for adaptability of new products to the existing sterilization protocol
  • Annual Re-validation for all sterile products.
Reverse Engineering
  • Reverse engineering for Cost Reduction of current products
  • Reverse engineering for improvement of safety and stability of current products
  • Reverse engineering for modification or extension of usage for current products
  • Reverse engineering for new market or regulatory requirements of the current products
Process Development and Engineer Assistance

Act as extension of your team to provide economical support on your innovative creation process, support including:

  • Materials sourcing and testing
  • Design and modelling
  • Product and Process validations
  • Product registration
Design Verification

Verification is carried out in every stage of development to fulfill the design requirements.

Product & Process Validation

Validation is necessary to assure a safe product can be produced under the validated and repeatable processes.

Packaging Validation

Packaging validation is performed according to ISO 11607.

Sterilization Validation

Validation and Re-validation on all the sterilization processes.

Material Testing

Different tests are carried out in house or through third parties to ensure materials safety, including its biocompatibility and ROHS compliance, and that the choice of material meets the customers’ requirements.

Accelerated & Real Time Aging test

Aging test is important to determine the shelf life and safety of a medical device. Our accelerated aging test methods use environmental chambers to determine the effects of temperature and humidity in compressed time. Besides, real time aging test is also included as part of our new product development process.