Medical Devices

Production and distribution is the key to consistent compliance with federal and international regulations. Indeed, it is the successful integration of these functions that leads to marketing competitive health care products that are safe and effective. Our experts support you.

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We help you to implement effective product development and regulatory programs that are customized and integrated with your engineering, manufacturing, quality assurance, procurement and distribution functions. Our product experience includes implantable/non-implantable, in-vitro diagnostic, sterile and single use disposable devices in both low and high volume automated production and software controlled devices.  

Our services for medical devices include

  • Assist in designing regulatory strategies
  • Validate products and processes
  • Perform “friend of the company” quality systems and regulatory compliance audits
  • Manage and respond to FDA inspections and ISO audits to rectify observed deficiencies
  • Establishment registration and device listings
  • Develop and implement FDA QSR and ISO compliance programs customized to company operations
  • Prepare product documentation, bill of material structure and product configurations
  • Design controls, corrective action, monitoring and trending programs and reduction of product costs
  • Assistance in obtaining ISO and CE Mark approvals
  • Provide training in quality and regulatory compliance

A global network for medical devices

Our experts and specialists worldwide can help with your individual queries related to medical devices. Get in touch!