Arena Blog

Keys for CAPA Success

IntroductionEstablishing Current Good Manufacturing Practices (CGMPs) ensures that medical device manufacturers can better comply with regulations and standards like FDA 21 CFR part 820.100 and ISO 13485, including quality systems that identify, analyze, and correct quality issues. These corrective and preventive action (CAPA) processes are a major component of delivering […]

Jan 22, 2019

Navigating the 510(k) Clearance and PMA Approval Process

IntroductionThere are two main paths that medical device manufacturers can use to bring moderate- and high-risk devices to market with the FDA’s permission: through submittal of a premarket approval (PMA) request or 510(k) application.Submitting a PMA application is a more extensive approach, requiring substantial evidence that provides “reasonable assurance that […]

Jan 9, 2019

Three Quality Subsystem Improvements That Streamline FDA Compliance

IntroductionMaintaining readiness for FDA inspections can be arduous and time-consuming, and the need for preparedness is growing. While the FDA continues to issue more observations than Form 483s, the number of observations has been decreasing, while the count of Form 483s has been increasing. A renewed focus on the quality […]

Dec 12, 2018

Eliminate Barriers to Innovation Part IV

Connecting Products and Projects Helps Streamline Regulatory ComplianceThis is the fourth and final part of our series on how to break down the barriers to product innovation. We have demonstrated how to connect disparate product teams with a single source of truth to simplify collaboration, streamline new development, and keep […]

Dec 4, 2018

Eliminate Barriers to Innovation Part III

Meeting Product Requirements and Streamlining Engineering Changes Throughout this series, we have been exploring how manufacturers can streamline new product development and new product introduction (NPDI) by connecting the entire new product team with a centralized product record for a single source of truth. During the first installment, we covered […]

Nov 26, 2018

Eliminate Barriers to Innovation – Part II

Bringing Teams and Products Together In the first part of this series, we discussed the three largest challenges companies face in developing and manufacturing products through new product development and introduction (NPDI) processes:    A complex environment of global regulationsGlobally distributed NPD and NPI teamsCross-functional IoT design in a world of […]

Nov 15, 2018

3 Key Challenges Facing Medical Device Quality Leaders

Medical Device Quality PressuresQuality leaders face a lot of pressure in their role in delivering safe, high-quality products to market. In the medical device industry, that weight is even greater as the quality of their products can have a direct and dramatic impact on a person’s health. Successfully navigating a […]

Nov 2, 2018