ERP for Medical Device Manufacturers2022-03-03T17:36:40-05:00

ERP for Medical Device Manufacturers

Reduce Compliance Risk and Scale Operations with Infor ERP

Copley Consulting Group has successfully implemented Infor ERP on behalf of dozens of small- to mid-size medical device manufacturers across the United States. Infor CloudSuite Industrial (Syteline) is a proven single system that helps medical device manufacturers maintain strict quality management and detailed product information, while fulfilling stringent regulatory requirements.

Outcomes Manufacturers Can Expect

One Enterprise Wide System

Eliminating or connecting disparate systems means better control, process automation and scalability

Double-Digit % Cost Reduction

Better control and automation equals time savings and safeguards that significantly reduce costs

Elimination of Compliance Risk

Meet FDA requirements and ISO 13485 certification, and obtain compliance across the U.S. and Europe

100% Paperless Operations

Enjoy efficiencies and save trees thanks to an electronic device record, bar-coded inventory, and much more

Enhanced FDA Compliance Capabilities – Only with Copley

Copley Consulting Group is the only Infor Gold Channel Partner to offer these additional regulatory compliance solutions for medical device manufacturers.

DMR/DHR

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DMR/DHR

Every record on building and testing a medical device is kept in a device master record. Any material proving your device is compliant is included in the device history file. Keeping your files well organized in an industry-specific medical device ERP system is essential.

Full Lot & Serial Traceability

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Full Lot & Serial Traceability

Every component of a medical device is lot traced. The trace functionality starts from the very beginning upon receipt of the material and is tracked to the specific work order that utilizes the traced material and the finished good.

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Quality Control

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Quality Control

Medical device manufacturers need an integrated quality system that is designed to fulfill ISO-certified operations. To stay within FDA guidelines, Infor SyteLine follows a specific focus in processing inspections, non-conformance, and corrective actions.

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Approved Vendor Management

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Approved Vendor Management

Infor SyteLine keeps records of your entire lifecycle from the idea stage to when it is available for users. When it comes time for an audit you will be expected to show how you manage your suppliers and ensure that the parts you are supplied with are compliant with regulations and meet your specifications.

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eSignature Controls

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eSignature Controls

The faster you can deliver your products, the better. eSignature Controls help you launch products sooner by increasing the efficiency of your approval and agreement processes, all while supporting your global compliance needs.

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CoA & CoC Report for Manufactured Lots

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CoA & CoC Report for Manufactured Lots

CoA & CoC reports document the quality assurance and confirms a regulated product meets the product specification. These contain the actual results obtained from testing performed as part of quality control of an individual batch of a product.

  • DMR/DHR

    Every record on building and testing a medical device is kept in a device master record. Any material proving your device is compliant is included in the device history file. Keeping your files well organized in an industry-specific medical device ERP system is essential.

  • FULL LOT & SERIAL TRACEABILITY

    Every component of a medical device is lot traced. The trace functionality starts from the very beginning upon receipt of the material and is tracked to the specific work order that utilizes the traced material and the finished good.

    Learn More

  • QUALITY CONTROL

    Medical device manufacturers need an integrated quality system that is designed to fulfill ISO-certified operations. To stay within FDA guidelines, Infor SyteLine follows a specific focus in processing inspections, non-conformance, and corrective actions.

    Learn More

  • APPROVED VENDOR MANAGEMENT

    Infor SyteLine keeps records of your entire lifecycle from the idea stage to when it is available for users. When it comes time for an audit you will be expected to show how you manage your suppliers and ensure that the parts you are supplied with are compliant with regulations and meet your specifications.

    Learn More

  • ESIGNATURE CONTROLS

    The faster you can deliver your products, the better. eSignature Controls help you launch products sooner by increasing the efficiency of your approval and agreement processes, all while supporting your global compliance needs.

    Learn More

  • COA & COC REPORT FOR MANUFACTURED LOTS

    CoA & CoC reports document the quality assurance and confirms a regulated product meets the product specification. These contain the actual results obtained from testing performed as part of quality control of an individual batch of a product

Copley’s Proven ERP Implementation Approach

For nearly 30 years, Copley has perfected a custom ERP implementation process for manufacturers seeking varying degrees of partner involvement, a flexible fee structure, and on-time deployment. The following table highlights Copley’s three stages of implementation, which can take place on premise or in the cloud.

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G2 Reviews

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Our FDA Regulated Clients

 
 

Our FDA Regulated Clients

 
 

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Case Studies

HemoSonics Implements Copley’s FDA Extended Solution

HemoSonics is a medical device company offering a novel point-of-care diagnostic platform to guide the management of critical bleeding to improve outcomes and reduce healthcare costs by enabling more targeted transfusion of blood products.

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Triangle Accelerates Growth With Copley’s FDA Extended ERP Solution

Triangle Manufacturing Company Inc. was founded in 1955 and continues to bring to life a wide range of medical instrumentation and implantable devices at a time when reliable sourcing is more important than ever. Triangle’s work impacts almost every part of the human body, demanding a level of precision and quality unlike any industry.

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Copley’s FDA Regulated Resources

Quanterix

BionX Medical Technologies

HART (Harvard Apparatus)

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