Regulatory Healthcare and Medical Device Compliance

Regulatory compliance in healthcare from FDA and EU-MDR to sustainability to export control

For medical device manufacturers, improving patient outcomes and achieving regulatory compliance are one and the same. However, the extra effort that regulation brings is eating away limited R&D budgets. Windchill is the product quality and compliance backbone that reduces the time and money medical device manufacturers have to devote to regulatory compliance.
Our solutions support medical device compliance by enabling manufacturers to manage, control, and track continuously evolving product information—helping teams reduce costs, improve re-use, create auditable records, and reduce lead times. The result is less time spent chasing regulatory information, traceability for finding and fixing problems early, and a ready-made audit-trail that serves as controlled evidence in conversations with internal and external auditors.

For medical device manufacturers, improving patient outcomes and achieving regulatory compliance are one and the same. However, the extra effort that regulation brings is eating away limited R&D budgets. Windchill is the product quality and compliance backbone that reduces the time and money medical device manufacturers have to devote to regulatory compliance. <br /> Our solutions support medical device compliance by enabling manufacturers to manage, control, and track continuously evolving product information—helping teams reduce costs, improve re-use, create auditable records, and reduce lead times. The result is less time spent chasing regulatory information, traceability for finding and fixing problems early, and a ready-made audit-trail that serves as controlled evidence in conversations with internal and external auditors.

Traceability and audit readiness

Create, plan, and execute audits to establish a quality governance process. Respond faster to adverse events and prevent multi-million dollar recalls. Post manufacturing service becomes more efficient.

Utilize best practices for lifecycle, workflows, attributes, and reports Less time chasing regulatory information

Harmonize and standardize across projects, disciplines, and geographies. Create a design history file (DHF) that represents the entire lifecycle of the finished device from design to commercialization, eliminating delays in putting products to market.

Automate time-consuming manual processes and minimize regulatory overhead

Generate regulatory submissions on demand from a single repository, which are automatically synchronized with engineering innovation. Automate and track SOP notification and training.

Digital thread for regulatory compliance in healthcare

PTC has the broadest suite of best practices to deliver value across the digital thread. From patented design control capabilities, through to regulatory submissions, PTC has helped our customers achieve efficiency and quality gains that are propelling medical device manufacturers forward.

Windchill Product Quality extends the industry’s leading PLM solution with best-practices for compulsory ISO 13485 processes including support for integral risk, CAPA, nonconformance, and complaint management—all linked to the digital bill of information for your product. It’s available as a cloud offering to speed your time to value.

Windchill provides a unified hub of truth that can be shared across medical engineering, quality, supply chain, and regulatory teams. Windchill creates a product, document, and quality backbone that ensures stakeholders are fully connected to the current state of the product throughout the entire lifecycle, reducing lead times, increasing efficiency, and reducing the costs of poor quality and regulatory compliance in healthcare.

Quality management

Improve customer satisfaction and adhere to medical device compliance by continually improving product quality while reducing service calls.

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Change and configuration management

Deliver a real-time view of the most accurate product data to all enterprise stakeholders by making dynamic, fast-paced, coordinated changes throughout the product lifecycle.

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Requirements and test management

Provide holistic visibility into evolving requirements that are centrally managed so stakeholders can more readily perform tests against requirements for faster and more reliable validation.

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Regulatory compliance in healthcare case studies

See how PTC’s medical device industry customers are embracing digital transformation to reduce their time to market, improve product traceability, achieve change management, and more.

Smith + Nephew

Smith + Nephew is using a PLM-enabled digital thread to improve traceability throughout its products’ lifecycle across all business units.

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Bose

Bose is using Windchill PLM to achieve document control, full-track change management, and co-managed BOMs, resulting in accelerated time to market, QMS validation and FDA clearance.

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CONMED

CONMED improved the safety and efficacy of their products by using Windchill PLM to unify their core regulated processes, quality management, and product development into a single system.

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Regulatory compliance in healthcare technologies

Windchill PLM software

Windchill provides the foundation and continuity of product and quality information across the digital thread, whether delivered on-premises or SaaS. With a validation-ready cloud, medical device companies and their design/manufacturing partners can take advantage of enterprise and multi-enterprise secure collaboration. Plus, Windchill’s out-of-the-box pre-configured ISO 13485 processes can be implemented quickly.

Windchill add-ons for industry-, role-, and task-based functions

Enable expert users to leverage and augment traceable and associative product data in the context of their job function or industry. Access highly tailorable workflows that automate once-manual processes to save time and standardize best practices across the enterprise.

Windchill risk and reliability

Windchill Risk and Reliability is a fully integrated software suite for both large and small manufacturers. Develop higher-quality, more reliable products using powerful analysis engines and built-in regulatory and industry standards.

Windchill PLM software Transform product lifecycle management across your enterprise.

Windchill add-ons for industry-, role-, and task-based functions Tailor your PLM solution to achieve exactly what you need.

Windchill risk and reliability Advance your quality management across the product lifecycle.

CIMdata’s closed-loop quality tool

Most, if not all, manufacturers face costs associated with poor quality due to design errors, field rejections, and warranty claims. But they often don’t know the best way to address these issues and in what order to gain the most benefit.

Use this interactive tool from industry analyst CIMData to gain insight into how to best address your key quality-related challenges. Get industry-proven recommendations for next steps and advice on what software capabilities can maximize the impact you see in these areas: