Medical Device Solutions

Ensuring Compliance, Improving Efficiency,
and Accelerating Time to Market

DOCUMENT CONTROL FDA
		ISO
AUDIT MANAGEMENT

Medical Device Solutions

Looking to Ensure Compliance, Improve Efficiency, and Accelerate Time to Market? The road from designing a new medical device to its actual delivery to recipients is long, bumpy, and expensive. Medical device manufacturers can lose millions of dollars in revenue for each day a new medical device is delayed from being delivered to market. If a new product is approved, the company manufacturing the device enters the next expensive phase: mass-production. To stay on top of this intense business and regulatory demands, medical device companies of all sizes throughout the world are turning to Orcanos to automate and streamline processes and enhance product development lifecycles, from concept to commercialization.

Solutions Specifically Designed for Medical Device Companies

Medical device companies have unique needs when trying to get their products to market faster while reducing overall costs and increasing internal efficiency. Orcanos produces software solutions that meet these needs by enabling medical device manufacturers around the world to enhance efficiency and implement effective processes. Our Solutions include:

Document Management

Thousands of documents generated throughout a company’s product lifecycle—such as those in the design history file (DHF) and device master record (DMR)—require a formal document management process to facilitate cross-functional collaboration and to ensure that documents are easy to track, retrieve, revise, approve, and share departmentally. Without an efficient system for managing documents, thousands of man-hours will be spent on even the simplest tasks. Orcanos’s document management solution provides a secure, web-based system for centralizing document collaboration and document control that improves efficiency, accelerates time to market, and ensures compliance.

Supplier Management

The complex process of accurately tracking suppliers on a company’s approved vendor list (AVL) requires continual management and monitoring. Such processes become exponentially more difficult as product designs and manufacturing processes change over time. Further complexities arise as increasing numbers of suppliers interface with different departments and divisions across the company. Orcanos offers companies the capability to efficiently manage and approve vendor lists and effectively track supplier quality and supplier status. Orcanos also automatically contains all supplier status and quality information (such as non-conforming material, COC, QC reports) in a single, easy to access location.

Risk Management

A consistent approach to assessing and managing risk is crucial to the successful quality and compliance management and precludes reputation damage from recalls or regulatory action. Orcanos integrates risk management throughout the organization to help unify all documentation and risk-related activities in a single centralized repository while providing a complete and accurate picture of the risk landscape across product lines and business processes.

Training Management

Tracking and documenting employee training is a regulatory requirement for the purpose of ensuring product quality. Orcanos automates the routing, tracking, documentation, training, and retraining of training tasks to help medical device companies meet rigorous regulatory requirements. Whenever there is a change in a Standard Operating Procedure (SOP) or other document linked to a course, all affected employees automatically receive new training tasks and notification via e-mail. Configurable training reports show pending, past due, and completed training, plus other critical information.

Quality Management

Quality event management is critical to success and profitability. By automating and effectively managing CAPA processes and integrating them with other quality endeavors, such as audits, nonconformances, customer complaints, and change control, Orcanos provides a foundation of excellence in controls, processes, and competency to guarantee that the solution implemented will provide the compliance results the organization demands and the methods and skills necessary for success.

Audit Management

Connecting audit processes with the entire quality system provide a holistic approach to quality management. Orcanos unifies and automates the scheduling of all audit-related activities to ensure that no vital processes are overlooked. With Orcanos, quality systems are consistently ready for inspections and audits.

Ten Reasons Why You Should Be Using Orcanos

1. A fully integrated solution that connects all departments throughout the organization
2. Reliable, consistent, and easy to use
3. Orcanos’s unique transfer operational qualification (TOQ) provides completed validation and support documentation of IQ/OQ tests performed onsite at Orcanos, providing documented evidence that the applications perform correctly against their specifications
4. Using an electronic, web-based system instead of paper-based systems saves time, resources, and money
5. Flexible system – new modules, add-ons, and connectors can be added as needed
6. Unparalleled expert technical support and customer service – support requests can be logged 24 hours a day
7. Intensive training is available
8. Compatible with most major integrators (i.e., Microsoft Office, Zapier, TFS, JIRA, GitHub etc.)
9. Used by more than by giant and smb customers, including hundreds of medical device manufacturers throughout the world.
10. Multiple languages and enterprise system architecture are designed specifically for multi-site, global deployments

Compliance Accelerated

Medical device manufacturers use Orcanos to meet key regulatory requirements while also increasing efficiency and keeping compliance costs down. Companies can enforce compliance
throughout every department and connect employees with relevant data and processes. The resulting environment enhances collaboration and allows managers to view all processes as a unified system. Call or visit www.orcanos.com to learn how hundreds of medical device companies are ensuring compliance and accelerating time to market.