Accelerating Innovation in Clinical Study Development
Empowering Medical Innovation with Regulatory Expertise
At SurgeSupply, we specialize in transforming medical concepts into market-ready solutions. Our team of experts in Regulatory Affairs, Clinical Affairs, Clinical Evaluation, Study Planning, Quality Management, and Software/AI collaborates to navigate the complexities of clinical development, ensuring compliance and efficiency at every stage. surgeSupply defines Regulatory Thinking® as an interdisciplinary regulatory strategy that knows existing rules, regulations, common specifications, standards and norms, adapts them to common and future technologies, uncommon healthcare settings or any new or unknown challenges, and applies them in the spirit of the “original idea.”
Our Services
Wearables
We assist in defining and implementing regulatory strategies for PoC devices, focusing on areas such as:
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In vitro diagnostics (IVD)
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Surgical applications in orthopedics, CMF, and dental surgery
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Preparation of surgical procedures
Our support ensures that PoC technologies are effectively integrated into healthcare settings
Regulatory Strategy & Quality Management
Our Regulatory Thinking® framework provides an interdisciplinary strategy that adapts existing regulations to modern technologies and healthcare settings. We assist in:
Developing certification strategies
Implementing quality management systems
Conducting audits and pre-assessments
This proactive approach ensures that your products meet the necessary standards for market entry.
Clinical Study Development
We offer comprehensive support in planning and conducting clinical evaluations, including:
Certification study planning
Literature reviews
Clinical evaluation report preparation
Regulatory strategy development
Our approach ensures that your clinical studies are designed and executed to meet regulatory requirements and achieve successful outcomes.
We are proud to be an RT Approved Vendor, officially recognized by Regulatory Thinking – a leading initiative that bridges the gap between regulatory compliance and strategic innovation in the MedTech industry.
Regulatory Thinking brings together top-tier consultants, educators, and industry partners to support startups, scale-ups, and established companies on their journey toward regulatory excellence. Rooted in a collaborative network that includes universities, notified bodies, and global experts, Regulatory Thinking empowers health tech innovators to align compliance with business success.
As an approved vendor, we meet the high standards of quality, expertise, and reliability that Regulatory Thinking demands. Whether it’s in the field of regulatory strategy, technical documentation, or market access – our solutions are vetted, trusted, and ready to support your path to certification and sustainable growth.
Our Partners
Our Customers:
