Medical Device Contract Outsourcer | Integer's Approach to MDO

Our Approach

From start to finish, quality and reliability are at the core of our collaborative partnerships.

Our focus is you.

The challenges you face when bringing a medical device to market are many. So, when it comes to an outsource partner, you need a team focused on your goals.

Partner with Integer for:

  • Deep expertise
  • A flexible approach
  • Vertically integrated supply chain
  • Maintaining strict confidentiality
  • A transparent approach to Intellectual Property
  • A global footprint

Our experience is your advantage.

Let Integer be your partner of choice for delivering results at a fraction of the cost. Our comprehensive approach supports you every step of the way, helping you reach project milestones faster while minimizing risks.

Quality – it’s at the heart of everything we do

Being certified and compliant with regulatory agencies across the globe, and in good standing, is only the beginning when building a quality medical device.

Integer quality experts go beyond the basics:

  • Quality systems compliant with global medical device industry standards – FDA, EU and ISO 13485:2016 – at all manufacturing sites
  • Well-defined set of quality KPIs routinely used for driving continuous improvement
  • Supply chain quality management program with controls to verify conformance
  • Risk-based approach throughout product life cycle
  • Robust quality agreements to assure alignment and clarify roles and responsibilities
  • Quality system architecture that encompasses multiple sites
  • Regulatory experts capable of supporting product registration activities in targeted geographies for device sales
  • Strong Notified Body relationship

Our values define us.

Our values represent the core of who we are, and guide the way we do business.

Integrity and Respect create the foundation for a positive working environment, and we accomplish our goals through effective Communication and Teamwork, as we strive to achieve Innovation and Customer Focus.