We are redefining how startups and innovators bring medical devices to market. Experts who simplify the complex accelerate your journey to market-ready products.
Comprehensive description
At IPP Dr. Volker Klügl, we are redefining how startups and innovators bring medical devices to market. Think of us as your regulatory co-pilots: experts who simplify the complex, optimize the essential, and accelerate your journey from idea to market-ready product. We’re passionate about empowering MedTech pioneers with lean, effective solutions that meet today’s regulatory demands—so you can focus on disrupting the industry and making a real impact.
Comprehensive Regulatory Guidance
We simplify the approval process for your medical devices by providing expert insights into MDR, ISO, and other regulatory frameworks. From strategy development to successful certification, we ensure your compliance journey is seamless and efficient.
High-Impact Technical Documentation
Our team prepares precise, MDR-compliant technical documentation tailored to meet stringent industry standards. With our expertise, you can confidently present the required files to notified bodies and regulatory authorities.
Agile Project Management
Stay on track with our flexible project management services, designed to align with your startup’s goals. We help you hit milestones on time, within budget, and in full compliance with regulatory requirements.
Process Optimization for Startups and SMEs
We design and implement scalable, lean processes to help you save time and resources without compromising quality or compliance. Whether you’re building your first product or scaling production, our optimized workflows grow with you.
Easy 13485: Your Smart QMS Solution
Managing compliance doesn’t have to be a hassle. With Easy 13485, our intuitive Quality Management System, you can effortlessly maintain compliance with ISO 13485. Designed for startups and growing companies, this tool streamlines document control, simplifies audits, and ensures your team stays ahead of requirements.
Tailored Consulting for Success
Every medtech company is unique, and so are its challenges. We provide customized consulting services that align with your specific needs, whether it’s preparing for a clinical evaluation or refining post-market surveillance processes.