How to unify quality management and compliance for medical devices

By Susan Hoey

Patient safety is fundamental in medical device manufacturing. That’s why stringent regulations and standards exist. You want to do the right thing for customers and ensure a high level of quality. But you also need to build a successful business model.

So, how do you navigate this complex balance between regulatory and quality management?
To continuously oversee compliance and quality procedures — all while ensuring patient safety— it’s crucial to implement digital tools that centralize your data.

Consolidate quality and compliance

To improve quality and compliance processes, it’s imperative to integrate and manage key quality data for traceability, efficiency and transparency. You then can gain access to comprehensive, up-to-date information for market submission and audits to ensure compliance, enhance interactions with authorities and better address product quality.

Through digitalization, you can bring quality and compliance efforts together throughout the entire device lifecycle with a solution that includes:

Track data with an integrated digital backbone

Siemens Closed Loop Quality and Compliance includes the data traceability tools you need to implement an integrated and collaborative digital framework. This ensures that siloed teams will be more coordinated on quality activities and data, and trace transparency will be established to keep track of standards and regulatory workflows, timelines and market differences.

Device product quality can be enhanced through prioritization of better solutions, information and processes — especially for new and complex medical technologies that can carry significant patient risk.

Ensure quality data continuity and feedback with comprehensive QMS

Quality and compliance process efficiency tools reduce risk through a quality management system (QMS) that ensures full traceability of design development phases through each manufacturing execution step.

Siemens process efficiency tools capture quality issues, customer complaints and non-conformances. They provide a process to investigate, analyze and resolve quality concerns, streamline measures to prevent recurrence, and report results clearly and intuitively.

A holistic approach to process efficiency enables your company to:

  • Achieve quality targets faster within NPIs
  • Minimize effort and capital costs
  • Reduce scraps and reworks
  • Avoid warranty, goodwill and recall costs

Facilitate transparency to internal and external stakeholders

Regulatory information management systems (RIMS) facilitate collaboration between the teams involved in regulatory affairs by providing easy access to all data in a single repository to improve communication with health authorities. They connect with existing systems and align with evolving company business processes to collect inputs from every lifecycle phase.

Our solutions also enable you to track deliverables for use outside of the system, such as pre-market submissions, including: 510(k), PMA and post-market reports such as PSUR, PMA annual reporting and post-market studies.

Automating regulatory affairs activities improves efficiency and global compliance, safeguards data accuracy and improves outcomes through the ability to modify tasks as regulations and processes evolve.

Create a quality-based culture

Quality is a matter that must be considered by every employee, not just the Quality department. Everyone needs to feel part of a complex ecosystem, where quality is a structured way to work.

Siemens Closed Loop Quality and Compliance for Medical Devices tools enable companies to bring together the forces needed to keep quality and compliance efforts harmonious. They automate the flow of documents and data to provide a variety of features not possible with traditional paper processes.

By adopting Siemens Closed Loop Quality and Compliance, manufacturers can achieve agility and peace of mind. You’ll ensure that the development process is connected and automated so that you can better innovate and bring safe, compliant products to market faster.

Read our ebook for further insights, or contact us, and we’ll show you how to continuously enhance compliance and improve device quality.

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This article first appeared on the Siemens Digital Industries Software blog at