Access to the IVD and Medical Device market means complying with a number of regulations and standards, which can seem daunting and costly. Fortunately, the solutions do not have to be. By understanding the different interpretations, applications, exceptions, and interactions among the standards, Proud Lion can help define optimal strategies for your unique situation. Our goal is to work with you to adapt your strategy to your risk tolerance, your timelines, and your ambitions, while providing hands-on implementation support. We can help you understand your go-to-market path for your new device, help you build a remediation plan for compliance issues, or help you implement a certification ready quality management system that is adapted to your organization and not just a set of off-the-shelf templates copied directly from the regulations.

Proud Lion has experience across the whole product life cycle from product development, manufacturing, and post-market activities. We have worked from products as simple as rapid tests to more complex systems including software and AI. Quality solutions should be as unique as your products and your company while fitting current needs. Investing in the QARA strategy early in product development can help avoid costly redesign or retrospective documentation later on. Proud Lion is proud to provide this service to start-ups and small companies who are not yet ready to have a full time QARA staff, but are aware enough to know that they need to be prepared.

Proud Lion is also available to help larger companies optimize and review their processes or their strategy. Too often a QMS can be bogged down by history, growth, acquisitions, or simply too many modifications over the span of years. Sometimes you need a fresh set of eyes to review the current practices and challenge the status quo to come back to pragmatic yet compliant solutions. Company integrations are also a challenging moment where Proud Lion can provide an independent moderation and advice on how to best integrate your QMS, Quality/Regulatory teams, and regulatory strategies.

Whether you’re looking for someone to conduct internal audits, audit potential partners, or assist your team in audit preparation or remediation, Proud Lion can help.

Internal audits are an important part of maintaining your quality management system and certifications, but small teams do not have the capacity (or independence) to audit themselves. With experience ranging from design and development, manufacturing, customer support, and post-market surveillance, Proud Lion can tailor an audit plan to your needs.

Working with a potential partner? Considering an acquisition? Having an understanding of their QMS capabilities and their current strengths and weaknesses is an important risk mitigation. Proud Lion offers an independent assessment of the company’s capabilities, strengths, and weaknesses around Quality, Regulatory, and Information Security. This can be useful in establishing a risk mitigation plan as part of your project as well as providing information toward eventual remediation costs. Discrete and with respect for all parties involved, these audits can be carried out quickly and independently.

If your team is interested in obtaining a new ISO certification (such as ISO 13485 or ISO 27001), a regulatory submission, or is having challenges dealing with an audit that recently did not go as planned, our Audit Preparation & Coaching services are designed for you. This package will be tailored to your unique circumstances. Proud Lion has experience in audits with the FDA, CFDA, ANVISA, ANSM, MDSAP, and a number of notified bodies. Let us show you the value of experience.

Qualification activities do not have to be boring. No one wants to watch the same generic recorded slideshow or online computer generated generic video over and over, and yet continued education and training are a key part of maintaining a compliant QMS. Proud Lion is available to provide tailored training solutions, keynote presentations, or educational workshops adapted for your needs. Our presentations are adapted to your target audience: from the pragmatic shop floor necessities to the short and targeted C-Suite exercises. Topics range from the operational routine, including building qualification plans for different parts of your organization, to the more strategic topics like business continuity exercises with your executive team.