Search
Close this search box.
DE

EN

Medical Devices Manufacturing Solutions

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

More Information
MES Solution

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.

Overcoming challenges in medical devices manufacturing–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.

Overcoming challenges in medical devices manufacturing–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.

Overcoming challenges in medical devices manufacturing–Technological advancement

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!

Overcoming challenges in medical devices manufacturing–Cost management

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.

InFrame Synapse MES product logo

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

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.

Core Features and Benefit

Inframe Synapse MES solution icon–complete product genealogy and traceability

Complete product genealogy and traceability – from raw to finished goods

Inframe Synapse MES solution icon–Integrated workflow engine to support different business processes

Integrated workflow engine to support different business processes

Inframe Synapse MES solution icon–Built-in audit trails for master data and transaction data

Built-in audit trails for master data and transaction data

Inframe Synapse MES solution icon–Unique industry-specific version driven by industry

Unique industry-specific version driven by industry

Inframe Synapse MES solution icon–Seamless GMP compliance and data integrity

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

Inframe Synapse MES solution icon–Fast and easy OpenAPI

Fast and easy OpenAPI

Inframe Synapse MES solution icon–Application Performance Monitoring (APM)

Built-in Application Performance Monitoring (APM)

Feature Highlights

Explore InFrame Synapse MES features for Medical Devices Industry

InFrame Synapse MES features highlight in medical devices industry regulatory compliance graphic image

InFrame Synapse MES 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
Pacemaker tool
InFrame Synapse MES features highlight in medical devices industry OpenAPI graphic image

Legacy System Integration

OpenAPI

  • Customer Dispatch Rules
  • DIY Equipment Integration
  • Low Code Integration of Customer Business Logic
OpenAPI logo
Swagger logo
InFrame Synapse MES features highlight in medical devices industry flexible extensibility graphic image

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)
InFrame Synapse Infographic
Download here

Implement a Role-Based Strategy in
Medical Devices Manufacturing Lines

Effective improvement of your teamwork performance

InFrame Synapse MES provides an effective improvement of your teamwork performance in medical devices manufacturing lines.
Implement role-based strategy for quality manager in medical devices manufacturing industry.

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.”

Implement role-based strategy for production manager in medical devices manufacturing industry.

Production Manager

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

InFrame Synapse MES provides an effective improvement of your teamwork performance in medical devices manufacturing lines.
Implement role-based strategy for process engineer in medical devices manufacturing industry.

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.”

Implement role-based strategy for equipment manager in medical devices manufacturing industry.

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.”

Implement role-based strategy for line operator in medical devices manufacturing industry.

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.

Explore camLine’s End-to-End Solution here >>

Play Video

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. ​

Play Video
Explore more
Work-Smarter video series

Explore More Pages

Dive into our collection of courses, whitepaper, and articles

camLine forum 2024 featured image
camLine's event

camLine forum 2024 – Define a Future with Digital Continuity

Read more
InFrame_Synapse_EC_3.0_Datasheet_EN_03
Equipment Integration and Automation

Powerful Interface for Easy-to-Use Equipment Integration

Read more
InFrame_Synapse_MES_5.0_Datasheet_EN_03
Manufacturing Execution System

Manufacturing Execution System for High-Tech Fabrication Sites

Read more

Have we piqued your interest?

Then contact us!

Get in touch
Get in touch






    The fields marked with an asterisk (*) are mandatory.

    You can use this contact form to contact us. We will use your personal data only for the purpose of processing your query. Your contact request will be processed centrally within the camLine Group to ensure that your inquiry can be responded to as quickly and effectively as possible. More detailed information concerning the collection and processing of data in connection with this contact form is available in our Privacy Policy.