Service

Quality Management

We can help your company fulfil its regulatory documentation requirements.

Megaforce has a robust quality manufacturing system with various certifications including ISO13485, ISO9001, Good Manufacturing Practice (GMP), and ISO14001, QC08000 and ISO45001 certifications further demonstrate our dedication to environmental preservation and workplace safety.

We are committed to our customer's success by focusing on safety, innovation and cost-effective solutions. We are also building the effectiveness of our quality and regulatory systems through continuous improvement.

Validating Your Products

We provide OQ and PQ batch production and relevant testing. Processing such as cleaning, dispensing, welding, compressing, interlocking, surface treatment plus others will be validated at each step prior advancing to mass production. The validation steps are paramount to the safety, efficacy and reliability of the finished product.

Test Method Development, Quality Control and Reliability Testing

Test method development is crucial for verifying against design inputs and outputs, and confirming product functionality with regard to quality assurance requirements (QA/QC). Product inspection is accomplished via manual and automated AOI systems. To complete final safety check, Megaforce performs reliability and useful life tests on all products built.

Documentation & Testing

  • Design History File
  • Device Master Record
  • Device History RecordI
  • ISO10993 Biocompatibility
  • ISO62133
  • ISO62304
  • IEC60601
  • IEC60601-1-2
  • IEC60601-1-8
  • UN38.3
  • ASTM D4169
  • ASTM F1980-21
  • Reliability Test
  • Sterilization Validation

Quality Assurance

Megaforce offers Quality Control services for medical products

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