Medical Device Quality/Validation

Source: SMC Ltd.

SMC Ltd. is ISO 13485 certified and our facilities are FDA registered. We strive to provide the highest level of quality for your products and medical devices. Our strength in providing upfront validation support (IQ/OQ/PQ) and proven regulatory compliance ensure your product repeatedly meets the required specifications. From initial design through manufacturing and delivery, our quality systems provide a high degree of assurance throughout the life cycle of the product.

With in-house automation, we can create systems that perform verification activities to provide repeatable outgoing quality levels. We are champions for continuous improvement, and seek to provide the ultimate responsiveness and focus to our customers. Our partnership and commitment to quality have been recognized by some of the top medical OEMs.

Our registrations include:

  • ISO 13485 certified facilities
  • ISO 13485 certified for design controls (SMC design center)
  • cGMP/QSR compliant
  • FDA registered manufacturing locations
  • ISO Class 7 and 8 cleanroom environments
  • Japanese Foreign Manufacturers Accreditation Certification

Contact SMC for more information on their quality and validation services as they relate to medical device manufacturing.

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