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Medical Devices Manufacturing Solutions

Your one-stop for a flexible, reliable, and efficient solution for medical devices manufacturing in achieving compliance with global regulations.

Ensuring Excellence: MES for Medical Devices Manufacturing

Medical device manufacturers are constantly dealing with ever-changing regulatory compliances, the pressure to ensure products are of the highest quality, and managing the complex global supply chain. With these tasks on deck at all times, manufacturers can benefit from abandoning the preceding paper-based methods and switching to advanced technologies to integrate innovative practices while maintaining cost-effectiveness and high standards regarding patient safety.

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Regulatory Compliance and Audit

The medical devices industry is no stranger to regulatory standards and evaluations to ensure the safety and efficacy of the product to patients. Whether it’s NDR, FDA, audits, or any other regulations, data integrity, quality, security, and traceability throughout the production process are of paramount importance.

Quality Control and Assurance

Traceability is the key to quality control and assurance by documenting every manufacturing process step. This can be crucial information for regulation and audit processes – even in case of a recall.

Technological Advancement and Integration

With the surge of technological advancements, digital solutions for the medical devices industry expanded. This brings a solution for a more effective and efficient manufacturing process and documentation – say no more to papers and physical archiving!

Cost Management and Pricing Pressure

The production costs can be high when prioritizing only the best quality outputs for the market and other factors. This can increase market prices, hindering its accessibility and affordability for consumers.

MES Solution for Quality, Compliance, and Efficiency in Medical Devices Manufacturing

InFrame Synapse: Medical Devices Edition

InFrame Synapse MES is the all-in-one manufacturing execution system solution for medical devices manufacturing and high-tech fabrication sites.

Have yourself a flexible and reliable solution with camLine’s InFrame Synapse MES in achieving cost efficiency and assisting to comply with the latest and relevant global regulations.

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Core Features and Benefit

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Complete product genealogy and traceability – from raw to finished goods

 
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Integrated workflow engine to support different business processes

 
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Built-in audit trails for master data and transaction data

 
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Unique industry-specific version driven by industry

 
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Seamless GMP compliance and data integrity with ALCOA+ principles' data collection framework

 
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Fast and easy OpenAPI

 
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Built-in Application Performance Monitoring (APM)

 

Features Highlight 

Explore InFrame Synapse MES features for Medical Devices Industry

InFrame Synapse Medical Edition


Regulatory Compliance

  • Electronic Batch Record (eBR) / Electronic Device History Record (eDHR)
  • Audit Trail
  • Electronical Signature
  • Based on ALCOA+ Principles and Data Integrity
  • Data Ownership
  • Checksum (SHA-2) against Data Manipulation
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Legacy System Integration


OpenAPI

  • Customer Dispatch Rules
  • DIY Equipment Integration
  • Low Code Integration of Customer Business Logic
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Software Solutions for Medical Devices Manufacturing


Flexible Extensibility

  • Statistical Process Control (SPC)
  • Supplier Quality Management (SQM)
  • Data Analysis / Design of Experiment (DoE)
  • Process Development Execution System (PDES)
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Implement a Role-Based Strategy in Medical Devices Manufacturing Lines 

Effective improvement of your teamwork perfomance

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Quality Manager

“I need to assure the best product quality, regulatory compliance, and impeccable audit results. Having production process transparency, accurate quality data, and the right software features can make my life a lot easier.”
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Production Manager

“I cover yield, material flow, and overall equipment efficiency. This includes the optimization of equipment status via reports, WIP-reports, and more.”
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Process Engineer

“Developing a continuous process is my part of the game. Therefore, I do need on-time data on the actual process in combination of product, process plan, consumables, recipes, etc.”
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Equipment Engineer

“Checking my equipment anytime is a must to better plan checks and maintenance. Therefore, I do need an overview of the status, process flow, and alarms of every equipment.”
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Operator

“I need to know what’s next. And where’s next? Which equipment/recipe setup? Some work instructions given to me would be nice.”

Integration with camLine Solutions

Our solutions offer real-time Statistical Process Control (SPC) including Out-of-Control Action Plans (OCAP), advanced Data Analytics, and comprehensive Workflow Management, helping you control, monitor, and optimize your automated manufacturing processes operations with unparalleled precision and efficiency.

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Trust Us as Your Partner: Start Your Project with camLine

Customer-oriented project consulting delivers high efficiency and quality to your battery manufacturing line. We believe that our expertise will deliver the best solutions for our clients and ensure successful project implementation. The basis for your project will be provided by software solutions with out-of-the-box capabilities and high stability. 

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Mirčo Krsteski
Key Account Manager
Work Smarter Video Series

Stay Ahead in the Medical Devices Manufacturing​

Unveil how the medical devices manufacturing industry can benefit from the right MES solution to ensure compliance, traceability, and quality control of outputs. ​

“InFrame Synapse MES is a reliable, flexible, and efficient solution for medical device manufacturing, ensuring compliance with global regulations, traceability for quality assurance, adherence to ALCOA+ principles, built-in audit trails, and cost-effective operations.”

Explore More Pages

Discover valuable resources—from our latest news, events, and webinars to white papers—that offer insights into manufacturing automation and innovation.

Let’s Discuss Solutions with camLine's Experts

Our team is ready to deliver tailored solutions that streamline your production, improve product quality, and maximize efficiency across your operations. Tap into camLine’s decades of expertise in digital transformation to overcome your manufacturing challenges.