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Medical Technology

Integrated Project Management Company, Inc. (IPM) applies more than 30 years of experience to the rapidly evolving medical technology industry.

IPM consultants apply valuable leadership, problem-solving skills, and state of the art project management and change management practices. Our consultants are Project Management Institute-certified Project Management Professionals (PMP). Most also hold advanced degrees (PhD, MBA, MS) and other certifications (Six Sigma, Lean, Agile Scrum).

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Engage IPM for:

Establishing design and development strategy and processes

  • Opportunity assessment and risk analysis
  • Research and development
  • Concept design and feasibility
  • Regulatory submissions

Commercialization: bringing products to market

  • Launch planning
  • Supply chain enhancement
  • Labeling and packaging
  • Product life-cycle management

Quality and regulatory processes

Compliance crisis management

  • Planning for, preventing, and managing crises and other disruptive events
  • Mitigating product quality regulatory problems, including recalls and remediations (e.g. 483 warning letters, complete response letters)
  • Managing Corrective Action Preventive Action (CAPA) processes

Corporate and organizational improvements

Contact us to discuss how we can help with your critical initiatives.

Featured Articles

Make the Case for Crisis Management Before the Crisis

Most people would agree that it’s better to prevent a crisis than to have to deal with one. But the reality is, by their nature,…

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Preventing and Managing Disruptive Compliance Challenges

Compliance challenges can create significant problems for life sciences organizations. Warning letters, consent decrees, product recalls, regulatory inspections, supply chain disruptions, and other crises have…

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MedTech Compliance Crises: Avoiding, Preparing for, and Learning from Disruptive Events

This article was originally published on MasterControl’s GxP Lifeline blog as How to Avoid—but Prepare for—Compliance Crises. What happens when a medical technology company gets…

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Disruptive Events: How medical device companies can deal with them head on and learn for the future

Read the article below or download the complete PDF: "Don't Let a Crisis Become a Disaster" → When you hear “crisis,” you think “COVID.” But a…

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Driving Innovation Through Changes to FDA Medical Device Regulations

The good news is that the FDA is enhancing review processes to ensure medical devices are safer and more effective. But are your new products…

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Steps to Accelerate Successful EU MDR Compliance

This article has been updated to indicate that the European Union Medical Device Regulation deadline has been extended one year, until May 26, 2021.  According…

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10 Tips for Leading Successful Medical Device Development Projects

Overseeing the development of a new medical device is a challenging undertaking. There are many moving parts involved in the process and risks and pitfalls…

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Optimized PPM Process Helps Medical Device Company Deliver Strategic Projects

The R&D team of a global medical device company was experiencing project slippage, diluted resources, prioritization problems, and too many projects within its current portfolio.…

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Beyond Compliance: Device Firm Reaps Benefits from Project Leadership

Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes…

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