From simple products people buy online today to expensive investments, consumers opt to easily compare products, opinions, and reviews online – these products can be as simple as headphones and as complex, personal, and regulated, as prosthesis. The amount of knowledge and information available to the general consumer today is comprehensive enough that consumers can prioritize quality, reliability, price, and user experience as their filters for choosing anything. 

 

Medical Device companies are highly regulated by the US Food and Drug Administration for if and how they can market their devices to the general public. Getting devices to market at the pace at which consumers want and need them is an enormous undertaking in not just regulatory compliance but also in maintaining quality, reliability, safety, and patient experience all the while controlling the price-point such that your device is more amenable than any competition, local or global. To do so, companies need to prepare filing dossiers and documents such as Design History Files (DHF), and Device Master Records (DMR) to establish that their device and design are safe to produce and match the quality threshold required for authorization. 

 

Quality and compliance guidelines are well-defined by the FDA and for medical devices to get approvals to market their solutions, either through a 510(k) Pre-Market Notification for generally lower-risk devices, to the more stringent Pre-Market Authorization typically required for class ii(b) and class iii medical devices that pose high risk to patients, medical device companies need to implement systems and processes to make quality-first and compliance-first a fundamental belief.  

 

Companies are currently often found maintaining quality documentation in various systems that stay siloed within the department that is creating them. It is famously observed that Medical Device designers store their design data in local servers and Product Data Management (PDM) systems. Quality teams often use a Quality Management System (QMS) to store all pertinent data: 

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• Complaints and non-conformance 

• Corrective And Preventive Actions (CAPA) 

• Document Control 

• Standard Procedures 

• Training Manuals 

• Hazard Management 

• Risk and Issue Management. And many more. 

 

The problem occurs when this data needs to be used by other divisions of the business to get ready for an audit, or 510(k) or PMA submission. For Medical Device companies to be truly quality-and-compliance centric, the bigger picture of the entire life cycle of the device is more critical. This means looking at optimizing several key business functions and processes. 

 

• Optimizing Design Controls as per 21 CFR Part 820 

• Requirements Validation through Simulation and Systems Engineering 

• Requirements Management for Mass-Market and Specialization. 

• Optimizing Communication, approvals, and reviews as per 21 CFR Part 11 

• Optimizing Medical Device Designs and Definitions 

• Unifying Document, CAPA, and Change Management 

• Optimizing DHF, DMR, and UDI management for regulatory filings. 

 

Read the full whitepaper to learn more about how the 3DEXPERIENCE platform allows Medical Device companies to implement a closed-loop quality and product development methodology with a single unified source of data.  

 

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Compliance with FDA guidelines about managing and maintaining design controls, requirements, Design History Files (DHF), Device Master Records (DMR), production plans, V&V plans and quality plans is an absolutely critical aspect of giving your medical device solutions a fair chance to enter the market. Preparing dossiers for 510(k) or PMA submissions.  

 

On Nov 19 and 20, 2019, Aventec in partnership with Dassault Systèmes is launching Accelerate: a Medical Device Innovation Summit with the goal of helping Medical Device companies ensure compliance, quality, and innovation remain the central pillars of your success. Learn more about the event to see whether you should attend. Register while spots are open. 

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