Does your organization maintain a Plan-Do-Check attitude? Quality and compliance don’t just happen; they come with management commitment, careful planning, execution and monitoring to ensure effectiveness. Let’s consider how a Plan-Do-Check strategy can help your organization meet internal and external customer needs.
Establishing plans for product design, risk management, quality control and validation of production lines are all expected in life science industries. These plans are often reviewed as part of regulatory inspections and audits. Plans provide a means for communicating intentions, responsibilities, resource allocation and methods to internal and external customers (including the FDA).
QualityHub’s subject matter experts and regulatory professionals can help your organization develop strategic plans for regulatory approval and commercialization of a new product. This includes guiding our clients through the right regulatory pathway, initiating early meetings with FDA to improve the likelihood of successful approval, and determining tasks necessary to support design transfer followed by commercial readiness (i.e. product realization).
We can assist in developing, organizing, and/or reviewing premarket submission content. Our former FDA associates can anticipate any questions reviewers may have, so these can be minimized in the review cycle.
Developing design plans concurrent with risk management plans are required by medical device regulations and ISO 14971, respectively. These plans are often complex and subject to regulatory inspection, so content and clarity are important. Planning for medical device development and risk management can help ensure tasks and deliverables expected by regulators (and necessary for the development of safe and effective products) are identified and agreed to by stakeholders.