Lynette Makowski serves as the Principal at Achieving RA/QA Compliance, LLC, where she leverages her extensive expertise in Regulatory Affairs and Quality Assurance to guide medical device manufacturers through the complexities of compliance. With a robust background in building effective relationships with global regulatory bodies,...
Lynette Makowski serves as the Principal at Achieving RA/QA Compliance, LLC, where she leverages her extensive expertise in Regulatory Affairs and Quality Assurance to guide medical device manufacturers through the complexities of compliance. With a robust background in building effective relationships with global regulatory bodies, Lynette excels in navigating the intricacies of FDA regulations and ISO 13485 standards. Her role involves custom designing and developing Quality Systems tailored to the unique needs of each client, ensuring they not only meet regulatory requirements but also enhance operational efficiency.
Under her leadership, Achieving RA/QA Compliance has successfully executed key projects that focus on improving Quality System processes and implementing robust CAPA (Corrective and Preventive Action) strategies. Lynette's proven track record in conducting worldwide audits has resulted in extraordinary outcomes, helping clients achieve compliance while fostering a culture of quality and continuous improvement. Her analytical skills enable her to dissect complex problems, providing actionable insights that drive product development and regulatory submissions.
In addition to her consulting work, Lynette is committed to educating clients on best practices in design control and software documentation, empowering them to integrate quality into every stage of their product lifecycle. Her dedication to excellence and her ability to forge strong partnerships make her an invaluable asset to the medical device industry, as she continues to shape the future of regulatory compliance and quality assurance.
