Meet Your Regulatory Compliance Requirements

How a Product-Centric Quality Management System (QMS) Improves Control, Traceability, and Compliance

Strategic Advantages

With increased specialization, outsourcing, and regulatory compliance initiatives, a single unified solution to manage product and quality information provides key benefits:

Improved Compliance

Medical device design and equipment manufacturers (ODMs/OEMs) must factor compliance throughout the new product development and introduction process. Otherwise, impacted teams will lose sight of, or have a difficult time addressing, the myriad of changing regulatory requirements.

Better Collaboration

Manufacturing, engineering, quality control, and compliance teams can more easily collaborate anytime and anywhere to reduce issues, control costs, and shorten the NPI process to gain first-mover1 advantages in the market.

Continuous Improvement

With a single unified system, internal teams and external partners can offer critical feedback at every stage, ensuring product issues are resolved as early as possible.

Underscoring the importance of compliance, LNS Research published the results of their quality management survey. In this survey, medical device company executives ranked the ability to “better manage operational risk” and “ensuring compliance” as their top two quality management objectives. The majority of executives also noted that having disparate quality systems and data sources was a key challenge to reach their quality management objectives (see chart below).2

Top Quality Management Challenges

When organizations rely on disparate systems to manage quality and product development processes, they struggle to identify, analyze, and resolve quality issues in a timely and accurate manner. With a product-centric QMS solution, medical device companies eliminate confusion and silos to improve knowledge sharing, support better design processes, and provide increased visibility across all teams.

The benefits are clear, but there is more you can do to help reduce additional challenges and risks with complex medical device manufacturers.