Project Management

We look forward to becoming your partner in your efforts to be in full compliance of EU regulatory requirements, whether you already have products within the EU or want to penetrate the EU market.  Similarly, we help you to obtain and maintain CE marking of your devices in a most efficient and effective way.

We approach each client with a passion to understand current and emerging business strategy, issues, risks and opportunities. Our goal is to provide meaningful, actionable insights and directly participate in assisting you with the achievement of your strategic initiatives. Our goal is to support and provide the analysis, critical thinking, objectivity and day-to-day support necessary to achieve your objectives to launch your products on time in full compliance of regulatory requirements.

We are a team of professionals who can offer the right combination of industry knowledge, experience and operational know-how to achieve the objectives of your initiatives. We work in an open and collaborative manner to achieve practical approaches to address your strategic, tactical and operational objectives.

Our  culture is founded on providing clients with an objective perspective on business opportunities, based on a careful assessment of the facts, risks, challenges and markets.  We understand the importance of effective risk mitigation in areas like regulatory compliance and how to organize initiatives aimed at transformational growth. Our team’s experience within the medical devices and life sciences industries affords us the ability to provide valuable, insightful and pragmatic advice.

Please contact us at any time to discuss how we can help you?

News

  • ‘Person Responsible for Regulatory Compliance’ (MDR: Article 15)
    [acronyms as QP (Qualified Person) and or CO (Compliance Officer) and or LP (Legal Person)] As recognised independent professional service provider we’ve developed (A) QP or CO services for SME organizations or manufacturers;  and (B) QP or CO Training Program. Our ‘Person for Regulatory Compliance’ holds an university degree in…

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