Epicor for

Medical Device

MANUFACTURING
Introduction
Meeting the Challenges for Medical Device Manufacturers
Epicor understands that businesses manufacturing medical devices face a unique set of challenges. Whether your
business is built on the creation of a single successful device or OEM manufacturers depend on you for components
in their end devices, providing the latest innovative technologies—alongside long product development cycles and
complex traceability requirements—inherently introduces business risk. Demographics are on your side. With today’s
aging population, a tremendous opportunity is available to successful medical device businesses who can manage
growth, while responding to market changes and adhering to the rigorous demands of the industry. These include
FDA 21 CFR Part 11 compliance, ISO13485, and cGMP in the United States and Regulation 2017/745/EU in Europe.

With increasing pressure to reduce prices in a business climate of expanding raw material costs, transportation costs,
and reduced labor availability, businesses like yours need to streamline and adopt new technology to automate
processes, gain competitive lead times, and reduce waste. Epicor for Medical Device is a global, cloud-based
enterprise resource planning (ERP) software solution designed for manufacturing and distribution organizations
that supply products and services to the Medical Device industry. Epicor for Medical Device enables a comprehensive
framework for managing product innovation with solid product data management, document control, quality
process controls, and cradle-to-grave product traceability.

Functionality
• Global operations
• Quality Management System (QMS), traceability and audits
• Cost management
• Rapid configuration and Product Lifecycle Management (PLM)
 Putting Your Customer at the Center of Your Business
For medical device businesses, customers are central to the development of the
innovative techniques and technologies that drive the industry. Responding with
agility and speed to customer demands helps you preserve a competitive advantage.
Customers may come to you with a wide range of understanding of medical devices.
Our solutions empower your workforce to address a wide range of use cases:
helping a patient with an implanted device, working with an in-home care worker
who services or uses the medical device, responding to a surgeon or doctor with
questions, educating and deploying the device via a global multinational channel, or
responding to the demands of Tier 1 or Tier 2 medical device manufacturers looking
for reduced cost and improved quality

The Epicor embedded CRM functionality offers a centralized customer repository

alongside comprehensive help desk functionality. Customer service details are
streamlined to enable rapid responses to inquiries as they happen. Embedded
workflow for issue escalation and resolution, along with full document control and
audit trail, maximizes your use of time and resources.

You can respond more efficiently to escalations by using the Collaborate platform.
Managing Rapid Growth These collaborative social tools allow engineering, production control, quality and
For many businesses, taking stock of core business operations in an integrated compliance, and service to subscribe to escalation groups and communicate quickly
fashion is the initial step in improving bottom-line revenues through greater on problem resolution and next steps. They can even facilitate direct collaboration
visibility into office, warehouse, and plant floor operations. Epicor for Medical with customers via Microsoft Teams® integration.
Device is a completely integrated solution for managing your business. From
initial concept and design through test plans, submissions, marketing and sales,
production and planning, sourcing and procurement, quality and delivery, and
finally financial recognition. Epicor for Medical Device has the integrated tools
to assist in your initiatives to grow your business profitably while improving
operational visibility and efficiency.

To help ensure a seamless implementation of your first ERP for startup Medical
Device manufacturers, cloud solutions like Epicor for Medical Device provide the
end-to-end capabilities needed to manage business needs now and quickly scale
as your business grows and needs change.

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 Financial Management Customer Relationship
Management

Service and Asset

Management Sales Management

Production Product Management

Management

Supply Chain
Management Project Management

Planning and Scheduling

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 Meet Strict Guidelines for Product Data and Quality
Product- and program-specific data guidelines for medical devices are especially stringent.
There are governmental and industry standards for recording products at the design,
production, sourcing, and delivery stages. Maintaining stringent product traceability, product
documentation, revision change control, and electronic signature is at the core of the system.
Epicor extends product data with end-to-end quality procedures, including online test results
for easier audits. Our solutions support these high-quality standards and traceability with full
non-conformance management, corrective actions, and preventative maintenance.

Additionally, the robust Epicor Product Lifecycle Management (PLM) is a complete end-to-
end solution developed to manage all aspects of a product’s lifecycle, as well as enable
enterprises to control the enormous amount of electronic documentation that they produce.
From engineering and submission, through production, fulfillment, and delivery, through
service and finance, you get complete visibility into the entire product history.

Product Traceability
In all regulated life sciences sectors, the need for traceability is critical. Epicor
for Medical Device features strong, cradle-to-grave control and visibility over lot-
tracked and serial-tracked parts, including serial genealogy of component products.
Additionally, Epicor for Medical Device offers strong fulfillment processes to allocate
parts directly to customer orders, including serial and lot designations. These strict
disciplines for traceability help ensure customer and industry requirements are met—
all while streamlining the shipping process.

Additionally, Epicor for Medical Device supports reference designator and manufacturers’
part cross-reference requirements for tracking electronic devices. Supporting the need
for enhanced traceability, Epicor delivers wireless capability in the warehouse and on the
plant floor—enabling you to track products in-process alongside raw material inventory,
finished goods, and supplied products. Epicor understands that complete traceability
throughout helps provide clarity and quick resolution in the event of audit or recall.

Collaborate is a unique solution that allows stakeholders to work together electronically

on product design and product issues. For added security, these interactions are stored in
a secure cloud location.

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Regulatory Compliance
Companies regulated by the FDA are required to validate their business systems. This validation needs to include the business processes deployed by your company within
the selected application. At Epicor, we understand this and can guide you on the services needed to assist your company in complying with validation requirements for
your installation, including business processes as they fit within your business framework. One of the challenges for businesses under validation requirements is keeping
current with the latest technology. In addition, updates to software require risk analysis and re-validation. Epicor Life Sciences Cloud solutions help provide the necessary
infrastructure, along with an upgrade cadence that not only supports the initial validation but ongoing validation requirements as well.

Epicor for Medical Device offers a robust framework in support of FDA 21 CFR Part 11 certification and audit, including comprehensive change logs with time/date stamps,
business process management that can deliver approval criteria for key processes, and a password validation for system-wide electronic signature capabilities.

Software Validation
On top of the other challenges facing medical device organizations is a set of governmental and industry-mandated regulatory requirements that demand tight control of
manufacturing process and traceability. From FDA 21 CFR Part 11 compliance to ISO 13485 and cGMP 820, today’s medical device manufacturer is faced with challenges that
may erode profits. Distributors of medical device products see similar challenges, including meeting strict requirements of the RoHS directive.

The Epicor robust infrastructure, coupled with its Quality Management suite, offers you a comprehensive approach to automating this compliance process while reducing the
risk of warning, recall, and customer issues.

Software Validation Partner

Epicor has partnered with IZiel Healthcare, a proven industry expert, to allow comprehensive validation support. IZiel Healthcare can streamline software validation for the
initial go-live, as well as establish a comprehensive software validation process for ongoing management.
 your business strategy changes. SOA offers a
Cloud Business Platform simplified infrastructure that helps make any future
Epicor delivers a scalable, cloud solution with mergers and acquisitions more streamlined.
a focus on agility so that you can adapt to the
changing business climate while remaining Supporting Extended and Global
confident that your critical business systems are Operations
secure and ready when you need them. The solution
delivers pragmatic innovation and the latest industry The market for most medical devices is a global
functionality, to help ensure you stay one step ahead one. Epicor understands the requirements of the
of the competition. global marketplace and can meet the requirements
for doing business on a global scale. Whether your
Epicor for Medical Device empowers every employee business represents a single entity, multiple entities
to learn the solution easily, thanks to an easy-to-use, within the same geography, or ranges across multiple
intuitive cloud-based user experience and embedded countries worldwide, Epicor can support you not
learning guides. only in doing business locally but doing business
between countries, including meeting classification
Made with manufacturers, for manufacturers, Epicor requirements of the Uniform Code Council (UCC).
combines deep industry capabilities withgreat user
experiences and the innovative technology to help Epicor for Medical Device offers comprehensive multi-
you grow. site capabilities coupled with a global presence to
meet your company’s requirements for local support.
Epicor for Medical Device comes with a suite of Competing globally and domestically—bridging
essential web services tools including Epicor Service geographic and strategic diversity and eliminating
Connect, Business Process Management (BPM), and supply chain inefficiencies—is possible with the right
Epicor Mobile Access that make internal and external technology. The Epicor industry solution streamlines
collaboration a reality. BPM, in particular, introduces intra- and inter-company processes and helps
granular control of business processes—you can use companies communicate quickly and accurately.
it during any process to gain additional information,
validate authorization against login, or automate Synchronization of the complex relationships which
operational steps to eliminate the risk of error. determine supply, demand, and fulfillment is the
means to reaching new, industry-leading levels of
Supporting your business strategies with applications business performance. Epicor for Medical Device can
built on a service-oriented architecture (SOA) helps help you achieve maximum efficiencies across your
you meet the immediate requirement for scalability globally extended enterprise.
while supporting an open philosophy in the event

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Flexible Cloud Options
Leadership in global cloud ERP is in the DNA of Epicor. Meeting the changing needs
of your business with flexible cloud solutions delivers on business growth today and
wherever the future may take you. Kinetic is ERP lets you choose your deployment:
public cloud, on-premises, or hybrid cloud. Hybrid cloud allows businesses to step
into the cloud with extensions without running their entire ERP in the cloud. As the
solution uses the same technology, regardless of cloud or on-premises, businesses
can also choose to self-host the solution or work with a third party. Multinational
organizations benefit from additional flexibility, as distributed business units have
deployment choices across the enterprise with some sites choosing cloud and others
choosing on-premises deployment.

Industry Leading Services and Support

Epicor is committed to offering industry-leading services and support for cloud-
based solutions to help meet the dynamic needs of businesses as they navigate
industry changes, customer demands, and competitive landscapes. Understanding
the unique challenges of medical device manufacturers, Epicor has partnered with
Iziel Healthcare to offer specialized support for software validation, helping to ensure
compliance with regulatory standards such as the FDA in the United States and EMA
in Europe. The Epicor Life Sciences Cloud solution provides support for ongoing
validation activities with documentation and annual upgrades that keep your
business up to date with the latest industry functionality to help your business grow.

Epicor for Life Sciences Cloud

The availability of secure, critical business systems in the cloud improves your ability
to compete and innovate with agility. The Life Sciences Cloud supports compliance
requirements with software validation on an ongoing basis. This solution includes
four cloud instances, combining regulatory documentation with an upgrade cadence
designed to meet strict life sciences regulatory requirements.

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We’re here for the hard-working businesses that keep the world turning.
You’re the companies that make, move, and sell the things we all need. Trust
Epicor to help you do business better. Your industry is our industry, and we
understand you better than anyone. By working hand-in-hand, we get to know
your business almost as well as you do. Our innovative industry solution sets
are carefully built to fit your needs and respond flexibly to your fast-changing
reality. We accelerate ambitions, whether you want to grow and transform, or
simply become more productive and effective.

That’s what makes us the essential partner to the world’s most essential businesses.

Contact Us Today: info@epicor.com | www.epicor.com

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disclaims, any implied warranties, such as fitness for a particular purpose, merchantability, satisfactory quality, or reasonable skill and care.
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