Laura Boll

Vice President - Regulatory Affairs and Quality at Diversatek, Inc.

Role: Vice President - Regulatory Affairs and Quality at Diversatek, Inc
Location: Milwaukee, WI, US
LinkedIn followers: 500 followers

About Laura Boll

Experienced Vice President of Regulatory Affairs and Quality with a demonstrated history of working in Class I and Class II/IIa medical device industries. Directly accountable for corporate quality, regulatory compliance, and premarket applications, including Person Responsible for Regulatory Compliance (PRRC) under EU MDR (2017/745). Responsible for managing quality/regulatory budgets and activities in geographically diverse locations. Experienced in U.S. Food and Drug Administration (FDA) 21CFR 803/820, ISO 13485:2016, Health Canada, EU MDD 93/42/EEC, EU MDR 2017/745, and MDSAP quality system regulations in all 5 jurisdictions. Experienced author of FDA 510(k), Q-Sub, and De Novo submissions; Health Canada Device Licensing; and EU Class IIa Technical File submissions and reviews under both MDD and MDR regulations (CE certificate under MDR regulations for Class IIa devices initially issued October 2022). Skilled in leading cross-functional teams in Design Development, Corrective and Preventive Action, Risk Management (ISO 14971), Analysis of Data, and Quality Control.

Experience

Vice President - Regulatory Affairs and Quality
Diversatek, Inc
Apr 2017 — Present

Contact information

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Current company

Diversatek, Inc

Medical Equipment Manufacturing · 21 employees · Founded 1982 · Germantown, Wisconsin, United States

Diversatek is a company operating exclusively in medical technologies, with deep and extensive expertise that drives the development of diverse product offerings. As a multi-platform healthcare solutions innovator, Diversatek market segments provide focus for strategic growth in Healthcare, Continuing Care and Contract Services. The Diversatek Difference is rooted in Innovation, Collaboration, Dedication and Accountability. It’s the active approach we take in the development of medical technologies and solutions in support of healthcare professionals, medical device manufacturers, home healthcare dealers, and ultimately, the patient populations they serve. Everyone at Diversatek shares the vision and commitment to invest, build and be the best—no matter what the medical technology. Through organic growth, new product development and strategic acquisitions, Diversatek is committed to technologies that simplify the complex medical marketplace and improve outcomes. As Diversatek continues to grow, we are proud to say that we will continue to be guided by untiring dedication to technical innovation, creative solutions and product excellence. Whether Healthcare, Continuing Care or Contract Services, we are resolved to collaborate across market segments and exemplify true enthusiasm for what we do. Diversatek employees are ensured comprehensive training, and have access to positions across our businesses. Strategic, tactical and operational decisions are made at the lowest level possible, enabling our employees to be at the center of everything we do. We promote from within, reward outstanding work and create opportunities for advancement. And just like you, we have high expectations. Learn more at http://diversatek.com/careers

diversatek.com

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