Certified

ISO 13485

Leading Contract Manufacturer

of RF Welded Products

  • 720 East Broadway Fortville, IN 46040
  • 317.485.7887

Certified

ISO 13485

Leading Contract Manufacturer

of RF Welded Products

Quality Management Systems for Start-Ups

QMS Made Easy

Increase your chances of a profitable medical device launch with a custom, quick-start quality management system designed to minimize risks, costs and delays to your product launch.

MedTech-Launch-Medical-Device-Development

Key components include:

Genesis Plastics Welding Sales & Engineering Staff
  • Custom setup and training to accelerate success, reduce risks and spending
  • Regulatory compliance management: FDA (21 CFR 820), ISO 13485
  • Risk analysis
  • Management responsibility
  • Resource management
  • Control of documents & records
  • Product realization (e.g. requirements, design specs, process control and more)

Custom, Right-Sized Approach

Often, quality management systems are built too complex to be useful, cost more than they’re worth, and take a long time to implement. What’s more, wasteful delays and regulatory slip-ups tend to follow quality management systems that are misaligned with your business size, scope and objectives.

 MedTech Launch helps you avoid those pitfalls by providing scope-limited, tailored quality management systems so you get exactly what you need — no more, no less.

 The offshoot: Faster medical device launches without sacrificing quality, needless spending, or regulatory compliance.

Evolving MedTech Design and Engineering for Launch Success

medical-device-design-process

Empowering Innovation for Go-To-Market Success

Let’s Discuss Your Project!

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