Medical Device Manufacturing

Challenges of Medical Manufacturing 

Combining the challenges of traditional discrete manufacturing with a high level of regulatory control via FDA and international scrutiny, medical device manufacturing presents a unique set of challenges.

You need more than just an IT system. You need an experienced partner with industry experience who understands your business challenges and can help drive solutions, a partner who can help you comply with the ever-changing FDA and international regulations while becoming more efficient. Hyla Soft can help.

Industry Expertise

From Product Lifecycle Management systems to streamline and manage your engineering data to full-blown 21 CFR Part 11-compliant Manufacturing Execution systems enabling Electronic Device History Records, we have the industry experience and technological expertise to help you improve your business.

Some key benefits of our services include:

  • Reduced cost and increased efficiency through the ability to create, approve, manage, execute, and review Device History Records electronically with fully 21 CFR Part 11-compliant eDHR Systems
  • Improved quality and fewer deviations by reducing/eliminating inherent human errors such as calculation errors, illegible entries, incorrect dates, and missing signatures
  • Improved visibility and communication through direct linking of engineers and engineering data to shop floor operators
  • Increased efficiency through rapid access to real-time data allowing for process monitoring and planning that can reduce the number of lost batches

Hyla Soft's Advantage

Hyla Soft is dedicated to creating lasting partnerships with our clients. By working together, we can identify the most effective ways to apply our technology solutions and industry know-how to your specific requirements. Let us put our experience to work to help your business succeed and thrive in the challenging Medical Device Manufacturing industry.

Interested in speaking to one of our experts? Contact us at

Featured Clients Mesfor Life Science Leader Feature Ima

Contact Us