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PLATFLOW

Medical Devices / Medtech

Platflow PLM for Medical Devices is an integrated end-to-end product development system that addresses complexity and regulation through reuse, context capture, and collaboration.

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As medical devices become more complex and regulatory oversight increases, it can be challenging for manufacturers to effectively deliver products and maintain a competitive edge. However, there are ways to enhance innovation, speed to market, and data quality while remaining compliant.

Digital initiatives can alleviate market and regulatory pressure if they work in sync. Approaching product development with the goal of reusing data and concurrent engineering can provide manufacturers with the agility to optimize design and differentiate their devices in the marketplace.

Platflow (PLM) for Medical Devices is an integrated end-to-end product development system that addresses complexity and regulation through reuse, context capture, and collaboration. Manufacturers can improve visibility and traceability while reducing costs and compliance risks to produce competitively differentiated, high-value devices.

PLM for Medical Devices integrates across disciplines to drive optimal product functionality. It is future-proofed to deliver safe, effective, and compliant products as demands change.

 

Speed up innovation through digitalization

 
PLM for Medical Devices offers features and performance that result in high-value devices with competitive differentiation. Digitalization, design authoring, and workflow tools come together to create a connected platform that produces low-risk devices with optimized performance.

PLM for Medical Devices encompasses three key areas:

  1. Design Data Management - Automate, standardize, and enhance product lifecycle and design authoring processes. Digitalization allows data to define, measure, analyze, improve, and control go-to-market management. Cross-domain synchronization enables teams - systems, mechanical, electrical, and software - to collaborate and share work in progress (WIP).
  2. Product Line Management - Manage, change, and manufacture product variations according to regional needs through visibility and integration across the value chain. Implementation improves the accuracy and structured definition of product and manufacturing specifications throughout your organization, including suppliers.
  3. Quality Process Management - Maintain a master system of record that is compatible with workflows and data traceability, history, and change management. Execute modular and discrete reuse of requirements, risk analysis, and testing objects from similar designs. Automate compliance, submissions, and reporting. Built-in compliance and design controls enhance product quality and data integrity.


What makes Platflow the ideal choice for Medical Devices?

For those in the medical device manufacturing industry, outcomes are the top priority. Platflow allows for the integration of quality beyond just the QMS, resulting in an optimal patient experience. A single platform combines quality, compliance, and product to aid your team in enhancing lives.

 

Advantages for Businesses

 
A 25% increase in the speed of resolving customer issues, 30% less effort required to attain compliance, and product launches that are 30% quicker.”

 

Solutions for Medical Devices:

Platflow PLM software solutions allow the management of product knowledge throughout the organization. Our solutions are trusted by medical equipment and are compliant with regulatory, engineering, and content and document management requirements.

 

The risks involved are intensified by competition, regulations, expenses, and organizational complexities. It is crucial to be well-prepared to face these challenges. Building the right product in the right way is essential.

To achieve this, decisions should be based on:

  • Integrating knowledge from different domains into a central, logical source that is accessible to everyone in the business.
  • Enabling decision-makers to make more coordinated decisions with others while understanding the impact of their choices on people across the enterprise, such as how mechanical design affects electronics.
  • The impact of electronics design on software or the ripple effect of a change throughout the entire system.
  • Facilitating cross-functional knowledge sharing and providing people with the information they need to act quickly.
  • A robust PLM system is the best way to maintain control and make informed decisions for development, manufacturing, and quality processes.

 

Essential Features of a Medical Device PLM

 
Compliance Management

Adhere to regulations such as FDA and EU, as well as industry standards like ISO 13485, 21 CFR Part 11, and 21 CFR Part 820. Ensure compliance with secure electronic signatures, password protection, action audit trails, and integrated risk management in all processes. A validation pack with executed IQ and OQ and template PQ scripts for all processes is also included.

Audit Management

Make data-driven business decisions and take preventative measures based on audit insights. Manage internal, external, and supplier audits and share information about upcoming audits and their results with relevant stakeholders.

Risk Management

Minimize adverse reactions by incorporating risk management into all processes. Include engineering change orders, CAPAs, and NCMRs in all processes. Calculate the risk score for events based on parameters such as issue severity and occurrence frequency using a reportable risk management matrix.

CAPA

Implement Corrective And Preventative Action plans, implementation plans, risk analysis, and effectiveness checks. Configure forms and workflows to meet your customer’s specific needs and expectations.

SCAR

Notify suppliers when a Supplier Corrective Action Request is in process and conduct supplier investigations and root-cause analysis in one central location.

NCMR

Integrate Non-Conforming Material Reports with other QMS processes such as CAPA and audits. Record non-conforming material and related supplier information using configurable forms and workflows to comply with FDA and ISO regulations while following industry best practices.

Customer Complaints

Address customer complaints and QA investigations to enhance product safety and increase customer loyalty. Integrate with Salesforce Service Cloud and other case management or customer service systems to gain customer insights. Meet specific customer needs with customizable fields and workflows. Reduce the risk of errors and non-compliance by using decision trees to determine regulatory reporting requirements.

Supplier Management

Manage the onboarding and qualification of new suppliers, support audits and electronic approvals, and collaborate with suppliers to quickly resolve product and supply chain issues. Minimize the risk of noncompliance and improve product quality. Understand preferred and alternate sources, field replaceable units (FRU), cost parameters, and part availability.

Deviation Management

Quickly identify deviations from standard processes to ensure compliance with FDA and ISO regulations and practices.

Training Records Management

Pass audits confidently and improve product and employee safety with a comprehensive training record management solution that includes full employee training transcripts, document-based training and quizzes, automated retraining, and training analytics. Manage employee certification on the latest product changes and processes throughout the product lifecycle to streamline regulatory compliance.

Equipment Calibration & Maintenance

Create Equipment and Maintenance records. Determine when Equipment requires routine Calibration and/or Preventive Maintenance. Manage Equipment Manufacturers, Site Location, Model and Serial Numbers, as well as Equipment Qualification and Software Validation.

Product Registration

Manage and track global product registrations and licensing for the countries where you sell. Plan, design, and forecast product and sales into new markets accurately. Streamline the creation, maintenance, expiration, and renewal of registrations. Ensure compliance, understand global impacts, and minimize inventory disruption.

eIFU (Instructions for Use)

Collaborate to manage the IFU throughout the entire product lifecycle. Publish accurate and localized versions of IFUs in the regions where the device is sold to eliminate errors typically associated with manual information entry and system integration.

Adverse Event Reporting

Automate reporting through decision trees, regulated agency tracking, support for electronic MedWatch FDA 3500A Form, and one-click submission. Keep track of outbound electronic eSubmission packages and all acknowledgements as proof for audits of reporting compliance.

 

Platflow is the only platform that manages the entire concept-to-customer lifecycle. It improves quality through supplier management and collaboration, provides engineering with quality data at their fingertips during design, streamlines compliance by tracking supplier performance and non-conformances and aggregating data for management reviews, and accelerates market entry by managing product registrations.

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