• Ensure Quality Systems align with effective processes
  • Balance Cost vs. Quality

Medical Device Quality Systems Solutions

Our medical device quality systems approaches provide assurance that systems are aligned and streamlined thus balancing cost vs. quality product outcomes. This critical variable often determines the reduction of non-routine quality events and increases profitability. Evaluating and implementing technology increases maturity, visibility and efficiency.

Medical Device Quality Systems Outcomes

Reduce non-routine quality effects

Integrate processes across the enterprise to drive business performance

Increase Visibility

Early detection of systemic risk

EngiLifeSciences 3PO Model™

Designed to help firms combat a volatile environment.

The model focuses on the four critical areas that impact change and drive the cost of change: People, Process, Performance Management and Organization. When these critical areas are aligned and optimized, industry change and conformance to new regulations can be implemented at a lower cost and with higher efficiency. EngiLifeSciences 3PO Model™ algorithm was created to drive operational efficiency so that when industry changes occur, there is a lower implementation cost and higher efficiency and execution.

The 3PO Model was designed to guarantee, at a minimum, a 1:1 annualized return on investment. Often there is a 2:1 or 3:1 ROI, sometimes greater.

EngiLifeSciences MEV Grid™

Designed to reduce clients’ costs, improve quality, streamline operations, and reduce the probability of recalls.

MEV Maturity – There are four distinct cycles within a Medical Device lifecycle: introduction, growth, maturity, and decline. Balancing cost vs. quality while preventing the probability of compliance observations, recalls or other major cost inhibitors allows a product to enter the maturity cycle. A device that enters the maturity cycle untouched by major events and expenses creates long-term sustainability and profitability.

MEV Efficiency – Efficiency is at the root of profitability. It drives costs down and brings medical devices to market in a timely manner. Although efficiency may sound like a soft term, it impacts every aspect of an organization including: people, cost, operations, product quality, even the susceptibility to recalls.

MEV Visibility – Visibility is being able to view, understand and analyze critical areas of operations, manufacturing, supplier procurement and more. Visibility is a critical feature to both operational excellence and supply chain management. If processes are not streamlined and visible, initiatives become vulnerable to increased costs and risks, decreased profitability and an overall loss of efficiency.

EngiLifeSciences Mev GridTM to create Maturity, Efficiency and Visibility throughout the organization.