CHADDS FORD, PA — ClariMed, Inc., the Delaware County-based medical technology company, recently appointed Liz Wellwood as Head of Quality. The appointment signals an expansion of the firm’s service offerings.
Wellwood, a seasoned professional with over 15 years of experience in quality management and operations, predominantly in the medical device sector, will now lead ClariMed’s quality initiatives. Her primary role will involve spearheading the development of new Quality service offerings.
In addition to this key appointment, ClariMed is introducing a comprehensive suite of quality assurance services that span each stage of medical device development. The goal is to meet stringent quality standards while enhancing usability and user experience.
The new suite of services encompasses:
- Document Control: This aims to streamline document lifecycle procedures for improved compliance and efficiency.
- Design Control: ClariMed will assist clients in validating the safety and user needs of medical and pharmaceutical products through effective design practices.
- Audits: The company will conduct internal and supplier audits to reinforce quality systems and meet regulatory standards.
- Risk Management: This service aligns with ISO 14971, ISO 9001:2015, and ISO 13485:2016 standards to proactively plan and design risk-tolerant quality management systems.
- Production Control: ClariMed will implement process checks to ensure product safety and efficacy while mitigating hidden costs.
- Complaint Management: The firm aims to create efficient systems for handling and responding to customer complaints, consistent with medical device reporting standards.
- Ongoing QMS Maintenance: The company will continually maintain quality management systems in areas such as ASL for supplier controls, monitoring CAPAs, NCMRs, and preparing documentation and statistics for regular management reviews.
Wellwood expressed her enthusiasm about the new role, stating, “I’m eager to grow ClariMed’s Quality practice and continue to align our QA services with human factors in medical device development. This integrated approach is key to delivering high-quality, user-friendly, and practical products.”
Kelley Kendle, CEO of ClariMed, also expressed her excitement about the appointment. “We are thrilled to have Liz join our team,” she said. “Quality as a service furthers our Quality by Design mantra. You can’t build quality in at the end—it has to be built along the way.”
The strategic appointment of Wellwood, coupled with the introduction of a suite of quality assurance services, signals a significant step forward in ClariMed’s mission to deliver top-tier, user-friendly medical devices that meet the highest quality standards.
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