7 Principles of Product-Centric Quality Management

A Guide for Medical Device Innovators

Bring Disconnected Teams and Siloed Systems Together

Supply Chain Synergy

Many companies develop or implement systems as they grow from young start-ups to more mature companies. This approach typically involves use of point solutions like Microsoft Word, Google documents, email, spreadsheets, network servers, file services, CAD design systems, or other homegrown solutions. This creates a patch-quilt system of silos to manage product and quality records. And, these systems lack a single controlled place to manage all related records by impacted teams.

What does working in disconnected silos look like?

  • Mechanical, electrical, and software engineers design in different tools that are used by their individual teams
  • Quality teams use document management or other quality management tools that are controlled and accessible only within their workgroup
  • Manufacturing and customer support teams use a variety of systems to handle planning, sourcing, and service
  • All of these teams have to rely on passing or sharing information via email, shared servers, or cloud storage

These disconnected silos make it difficult, if not impossible, to identify the latest design and track quality or manufacturing issues. Furthermore, executive management teams cannot get a complete picture regarding NPDI process performance and risks.

Team and Supply Chain Synergy

Quality RecordsMedical device companies today rely on distributed teams of experts to design, manufacture, and support their products. These experts can be direct employees, design partners, contract manufacturers, suppliers, or other contractors. Keeping these distributed teams aligned requires a single, connected solution. Without a single unified system, you will experience:

  • Difficulty identifying the latest revision of designs and confusion about which system has accurate information
  • Lack of visibility regarding product changes, compliance, sourcing issues, and manufacturing challenges

This disconnect typically results in product design delays, production problems, and increased product costs caused by scrap, rework, and resolution late in the NPDI process. Read more about connecting distributed teams in an era of accelerating innovation.

Traceability and Transparency - the Pains and Price of Software Validation

Sections

Introduction - Having a Rock-Solid Approach to Quality

Expedite Readiness for Regulations and Requirements

Go Beyond the Limitations of Document-Centric QMS Approaches

Assure Quality and Product-Centricity Throughout NPDI

Bring Disconnected Teams and Siloed Systems Together

Traceability and Transparency -  the Pains and Price of Software Validation

Setting the Stage for Success and Innovation

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