Contact Info

Services

• EU Authorized Representative [EC-REP]
• EU Regulatory Consulting
• Technical Documentation
• QMS Consulting
• Eudamed Consulting
• Training Services
• Internal Audits

Hours of Operation

About Us

🏆 Who We Are: At Specculo, we are your dedicated partners in conquering the intricate landscape of EU and UK regulatory requirements for medical devices and in vitro diagnostics (IVDs). As seasoned experts in regulatory affairs and quality management, we specialize in guiding manufacturers through the complexities of compliance, ensuring your products reach the market smoothly and swiftly.

🌍 Global Reach, Local Expertise: With a deep understanding of the European and UK regulatory frameworks, we seamlessly blend global insights with local expertise. Whether you're a startup with groundbreaking technology or an established player seeking market expansion, we tailor our services to your unique needs, fostering a regulatory strategy that aligns with your business goals.

💡 Our Services:

• Regulatory Consulting: From classification to post-market surveillance, we provide end-to-end regulatory consulting services tailored to your product portfolio.
• Quality Management: Elevate your quality systems with our comprehensive quality management consulting, ensuring compliance with ISO standards and regulatory requirements.
• EU Authorized Representative: Trust us to be your authorized representative in the EU, facilitating communication with competent authorities and enhancing your market presence.
• Training Services: Empower your team with our customized training programs, equipping them with the knowledge and skills needed to navigate the regulatory landscape effectively.

🤝 Why Choose Specculo?

• Proven Expertise: Our team comprises seasoned professionals with a wealth of experience in the medical device and IVD industry.
• Tailored Solutions: We understand that one size doesn't fit all. Our solutions are customized to meet the specific needs of your products and business goals.
• Responsive Support: Your success is our priority. Experience prompt, reliable, and personalized support throughout your regulatory journey.