Why Quality Execs Prefer a Unified Product Development Platform

Kim’s quality experience includes setting up companies’ quality management systems, hosting FDA and third-party audits, and auditing medical device manufacturers, having been a lead auditor for a European Notified Body. She has also filed many FDA 510(k) submissions resulting in clearances and obtained CE marks for various products. According to Khoe, the benefits of contracting with Apical include real dividends in production of effective product, reduced development time, lower overhead count, and quicker regulatory approvals—all to enable a delivered complete project. “Contracting with Apical to efficiently handle the design, prototyping, and manufacturing eliminates your need to organize a staff to support these efforts,” says Khoe. Prior to working at Apical, Khoe successfully implemented Arena for several international companies. To meet FDA and other regulations, Khoe knew she must be able to manage information in a controlled and secure manner to show evidence of compliance and avoid costly consequences, penalties, and brand damage. Early in her career, Khoe experienced the pain and burden of inefficient paper-based manual processes, which led to increased compliance risks and exposure caused by misplaced critical documentation that made it hard to prove mandatory compliance. Khoe and CEO Bruno Strul agree that having a product lifecycle management (PLM) system by itself—while an upgrade from manual processes—can still present problems if the PLM system is disconnected from the quality management system. The lack of visibility with siloed systems creates problems that can start snowballing fast. The classic case is when key crossfunctional team members are unaware of changes due to insufficient transparency—and a problem only presents itself just before shipping to market.

Apical Instruments is a medical device company located in Redwood City, California, on the San Francisco Peninsula. They have partnered with companies to design, develop, and manufacture quality medical device products. The benefits of utilizing Apical’s services include real dividends in production of effective products, reduced development time, lower overhead count, and quicker regulatory approvals—all to enable a delivered complete project. With over 30 years of experience in the medical device regulatory affairs and quality assurance fields, Apical Instruments Director of Regulatory Affairs & Quality Assurance, Kim Khoe, knows a thing or two about the keys to quality success.