Why Medical Device Industry Needs Cloud-based Solutions to Automate Quality and Product Lifecycle Management

Product development is an iterative process covering a range of activities such as ideation, design and development, launch, and upgradation. This requires the research and development team to keep track of the many changes to specifications and design - to conform to both regulatory and customer requirements. In the modern world of global supply chains, the need for teams to collaborate across geographies, be up to date with regulatory changes, and manage resource crunch can make on-prem systems restrictive and ineffective.

Some of the common challenges faced by product development companies relying on traditional methods include:

• Siloed Data: Traditional, on-prem systems tend to create silos due to the use of disconnected systems that make information flow difficult and hinder the development of high-quality products.
• Poor Collaboration: Product development is a collaborative process needing inputs from different teams. Every stage of the process also needs to be reviewed and approved before moving to the next stage. Real-time collaboration between the different stakeholders, some internal and some external including supply chain partners and customers, become critical and difficult in siloed systems. A timely response can become difficult and lead to delays.
• Prone to Errors: The absence of a centralized system for the different stakeholders necessitates a serial approach to review instead of a parallel one. Version control becomes a challenge and leads to errors and confusion, bottlenecks, and causes further delays and rework. Scrap and wastage due to the downstream teams such as production and purchase not being to get involved at an early stage are also added challenges.
• Noncompliance and Nonconformance: The risk of nonconformance increases due to the lack of synchronization of product and quality information in siloed systems. There is no traceability or visibility into the processes, and timely intervention in case of any issues to initiate the necessary corrective and preventive actions (CAPAs) becomes difficult. This increases the risk of noncompliance in the medical devices industry, which is a highly regulated industry and needs proper documentation and audit trails to get approvals.

These challenges impact product quality, performance, and acceptance - affecting brand reputation, and lowering revenue potential.

The adoption of new-gen technologies such as modern QMS and PLM can improve product design and development efficiency. It is also critical to meet overall quality goals. Let’s see how.

Benefits of a Cloud-based PLM for the Medical Device Industry

Cloud-native product lifecycle and quality management solutions improve efficiency by providing a connected system that enables a centralized view of the design documents and the bill of materials. This minimizes confusion and errors, improves visibility and traceability, permits version control and collaboration, and accelerates reviews and approvals. Even dispersed teams in disparate geographies can communicate and collaborate on a cloud-based system, enabling timely interventions and appropriate actions. Change management and sharing of information downstream become easy, increasing productivity and effectiveness, improving the quality of the products, and reducing costs.

Cloud-based PLM and QMS are scalable and flexible, enabling businesses to leverage digital transformation technologies such as AI/ML, IoT, and data management to break barriers to innovation and improve resource utilization.

Some of the other advantages include:

• Lower infrastructure costs with access to the latest technologies
• Jumpstart your product development processes by accessing a ready-to-use PLM with minimum configuration
• Easy customization to suit the individual needs of the company
• Immediate scalability based on the fluctuating demands of the development process
• Anytime, anywhere access, further speeds up the process as executives can access the system even when on the go
• Improved security as permission-based controls are put in place to authorize users based on need
• Improve resource utilization and minimize dependence on IT

ComplianceQuest’s Cloud-based PLM and QMS for Medical Device Industry

ComplianceQuest’s cloud-based PLM and QMS are built on Salesforce and capture the entire research, development, design, and manufacturing process of medical devices end-to-end, integrated with quality. This improves compliance, conformance, product quality, and speed of development. It improves visibility, collaboration, and traceability, providing an audit trail and version control, lowering the cost of development, and increasing productivity.

Some of the features that benefit the medical device industry include:

Design Controls: Allow your teams to innovate with effortless compliance to all quality and regulatory standards

Projects: Collaboration made easy for both engineering and quality teams with intuitive meeting and task management

DHF & DMR: A single source of truth for all your design documentation, that's always up to date

Document Management: All steps, requirements, design reviews, and changes are well documented, easily shareable, and fully compliant.

Requirement Traceability Matrix (RTM): Living document that keeps track of all your design requirements, inputs, tests, and changes

Product Risk: Assess, document, and control all your product-related risks in one comprehensive interface

A QMS-integrated design process provides the following benefits:

• It is fully connected
• Provides 100% real-time visibility
• It is completely traceable

The comprehensive platform allows organizations to manage quality and compliance throughout the product lifecycle. The integration of quality management and PLM within the CQ platform is achieved through several key features, including:

• Product Quality Planning: CQ provides a module for defining and managing product quality plans, which ensures that quality is built into every stage of the product development process.
• Change Management: CQ's change management module allows organizations to manage product changes, including change requests, impact analysis, and approvals, while ensuring that quality standards are maintained throughout the process.
• Nonconformance Management: CQ provides a module for managing nonconformances, which allows organizations to identify and correct quality issues as they arise.
• Audit Management: CQ's audit management module allows organizations to manage internal and external audits, ensuring that quality and compliance standards are met.
• Risk Management: CQ provides a module for managing risk throughout the product lifecycle, which helps organizations identify and mitigate risks that could impact product quality.
• Document Management: CQ's document management module allows organizations to manage product-related documents, ensuring that all stakeholders have access to the latest information.

CQ’s integrated PLM and QMS platform allows medical device manufacturers to improve product quality, reduce costs, and comply with regulatory requirements. The platform provides a centralized and unified approach to managing quality and compliance throughout the product lifecycle, resulting in better products, higher customer satisfaction, and a stronger competitive position.

To know more about the ComplianceQuest solution, please request a demo here:https://www.compliancequest.com/lp/eqms/