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Regulatory Compliance Software for Medical Device Manufacturers

Accelerating Time to Market for Medical Device Manufacturers

Quality, reliability and safety can compete with the business needs of medical device manufacturers. Stringent quality requirements, market pressures and product complexity all combine to create a host of difficult challenges to manufacturers.

Risk and regulation management can often have an adverse impact on time-to-market and the cost of manufacturing medical device products. Today, manufacturers have to meet, manage and maintain increasingly rigorous compliance standards while, at the same time, balance increasing commercial pressures.

At Ideagen, we support medical device manufacturers with key business functions that will ensure quality, reliability and safety are achieved throughout the product lifecycle. These include preventive actions to combat potential adverse events as well as reactive management methods. Our solutions:

  • Modernise and strengthen your quality management system
  • Ease Compliance with standards and regulations
  • Create a culture of reporting and safety
  • Substantially improve operational performance and efficiency
  • Control and protect reputation and brand
  • Help Anticipate and prevent problems and issues

Achieving and maintaining compliance with the FDA’s 21 CFR 820 and Part 11, ISO 13485, or ISO 14971 is of vital importance. Moreover, the current Medical Device Directive (MDD) is transitioning to the Medical Device Regulation (EU MDR) – devices placed on the market must meet these new requirements, and time to market may increase.

Ideagen's products and services cover this business need and deliver operational excellence in advanced manufacturing.

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Omega Diagnostics improve its compliance processes across multiple sites

"Q-Pulse makes it easier to tie information gathered from each site together in order to look for issues, synergies or trends to see if there are any opportunities for improvement and identify best practice."

Mike Gordon, Group Operations Director at Omega Diagnostics

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ISO 13485 Compliance

ISO 13485 is a globally recognised medical device standard and specifies requirements for a quality management system in order to ensure and verify that customer and regulatory conditions are met by the medical device industry.

Compliance with ISO 13485 can enable medical device companies to implement and streamline robust processes and procedures to ensure quality, reliability and safety are achieved throughout the product lifecycle. Within a shifting global market, consistently delivering high quality products or services can create competitive advantage for medical device companies. A robust product lifecycle that follows the principles of ISO 13485 can accelerate time to market and mitigate future risk for organisations.

Download the flyer for more information on how Q-Pulse can help to accelerate time to market

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Comply with ISO 9001: 2015

"There has been some debate internationally about the implications of the proposed changes for both quality and audit professionals. Some national bodies regard the changes as insignificant, taking the view that ISO 9001:2015 simply introduces a number of requirements that were previously implied in ISO 9001:2008 but that were not mandated."

"The CQI and IRCA do not share this position. We remain convinced that those leading, managing and auditing quality management systems will need to revise their current thinking and work in different ways in order to maintain organisational compliance."

— DIS 9001 2014, Understanding the Draft International Standard, IRCA and CQI

Risk, Leadership, Communication and Processes

The world’s most popular standard – ISO 9001 – is changing: a substantially updated and revised version will be published in 2015 to replace the 2008 edition. Ideagen works closely with compliance and risk industry analysts around the world and the most frequently asked questions they receive relate to the imminent changes in ISO 9001 are:

  • How do I extend my quality management system out to third parties in my supply chain?
  • In practice, how do we implement a risk-based model of quality management?
  • Where should we start?

Our White Paper responds to these questions: you want to know what the changes in the standard mean for your organisation, and you specifically want to understand how our products have evolved to help you prepare for and align with ISO 9001: 2015.

Read our white paper that explains how our software products and solutions can help you prepare for and comply with ISO 9001:2015.

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