CHADDS FORD, Pa., Jan. 29, 2024 /CNW/ -- ClariMed, Inc., the first end-to-end MedTech services partner to prioritize usability as the core of their integrated, human-centric approach to medical product development, today announced the strategic appointment of Liz Wellwood as Head of Quality, reinforcing its commitment to excellence in quality assurance and signaling the expansion of its service offerings.
Liz Wellwood is an accomplished professional with over 15 years of experience in quality management and operations, predominantly in the medical device sector. Liz will lead ClariMed's quality initiatives and spearhead the development of new Quality service offerings.
ClariMed is also introducing a suite of quality assurance services that address each stage of medical device development, meeting stringent quality standards while enhancing usability and user experience. These include:
- Document Control: Streamlining document lifecycle procedures for compliance and efficiency.
- Design Control: Assisting clients in validating the safety and user needs of medical and pharmaceutical products with effective design practices.
- Audits: Performing internal and supplier audits to bolster quality systems and meet regulatory standards.
- Risk Management: Aligning with ISO 14971, ISO 9001:2015, and ISO 13485:2016 standards to proactively plan and design risk-tolerant quality management systems.
- Production Control: Implementing process checks to guarantee product safety and efficacy and mitigate hidden costs.
- Complaint Management: Creating efficient systems for handling and responding to customer complaints, in line with medical device reporting standards.
- Ongoing QMS Maintenance: Continuously maintaining quality management systems in areas such as ASL for supplier controls, monitoring CAPAs, NCMRs, and preparing documentation and statistics for regular management reviews.
Liz Wellwood commented, "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."
"We are thrilled to have Liz join our team," said Kelley Kendle, CEO of ClariMed. "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."
About ClariMed
ClariMed is a human-centered development and regulatory practice for medical products developed by Pharmaceutical and Medical device manufacturers. Our best-of-breed professional services cultivate innovation while ensuring the safe and effective use of medical products. Visit us at www.Clarimed.com.
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SOURCE ClariMed
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