Month: April 2025

Achieving CE marking for a medical device starts with one of the most critical components in the EU regulatory process: the Technical File. But navigating the requirements of the EU MDR—and aligning your documentation with the expectations of Notified Bodies—can be complex.

In this expert-led webinar, Gsap and Dekra join forces to walk you through the essential elements of an EU MDR-compliant Technical File. From structure to strategy, the session provides practical guidance for regulatory professionals, QA teams, and innovators preparing for EU market access.

🎯 What You’ll Learn:

• A step-by-step breakdown of the EU MDR Technical File structure
• Common mistakes in submissions—and how to avoid them
• What Notified Bodies really look for during document review
• How to align your file with MDR Annex II & Annex III
• Tips for building audit-ready, CE-markable documentation

Whether you’re preparing your first submission or refining an existing one, this session equips you with the tools to streamline your process and increase your chances of successful EU approval.

🎥 Watch the full recording below:

Clinical trials are at the heart of medical innovation—but they’re not without challenges. From rising costs and recruitment hurdles to regulatory complexities, sponsors and CROs are constantly looking for ways to conduct trials more efficiently and effectively. This recorded webinar brings together experienced voices from Gsap and Medistat to share practical insights for optimizing clinical trial operations, particularly when working with limited resources or under tight timelines.

🎯 What You’ll Learn:

1. How to reduce trial costs and improve operational workflows
2. Strategies to enhance patient recruitment and retention
3. Regulatory insights to avoid common delays and pitfalls
4. Smarter budgeting techniques for early‑stage and growing companies
5. Real‑world case examples from both CRO and sponsor perspectives

Whether you’re leading a clinical team, supporting trial execution, or managing strategy and compliance, this session offers valuable takeaways to help you move forward with greater clarity and control.

🎥 Watch the full recording below:

Packaging validation is a critical step in ensuring product safety, sterility, and compliance with global regulatory requirements.

In this recorded webinar, experts from GSAP and Medimor Ltd. explore the practical aspects of building a compliant packaging system and executing validation processes that meet international standards such as ISO 11607, FDA, and EU MDR.

🎯 What You’ll Learn:

• How to design and validate a compliant sterile barrier system
• Overview of key validation tests: ASTM F1886, F1929, F1140, F88, and more
• Common regulatory pitfalls and how to avoid them
• Real-life examples from validated packaging systems
• Discussion and Q&A with validation professionals

Whether you’re involved in QA/RA, validation, production, or regulatory strategy, this session will help you ensure packaging integrity throughout the product life cycle.

🎥 Watch the full recording below:

Bringing a digital health product to market is complex, but with the right guidance, it’s achievable.

In this expert-led webinar, professionals from Gsap and Matrix Medika share practical strategies to help you navigate the key challenges in regulation, quality, and development for digital health products in the EU and U.S.

🔍 What you’ll learn:

• How to streamline your product development process
• How to avoid common regulatory and quality pitfalls
• How to reduce delays and improve submission success
• How to approach FDA and MDR approvals more confidently

Designed for startups, developers, and QA/RA professionals, this session is especially relevant for those working with SaMD, AI-based tools, and other digital health technologies.

🎥 Watch the full recording below:

Celebrating a Multi-Dimensional Success at Gsap!

At Gsap, we take pride in providing end-to-end support across quality, regulation, and clinical trial management (Gsap CRO), ensuring our clients achieve their goals efficiently and successfully.

Gsap CRO planned, executed, and managed the study end-to-end until the final CIR.

This month, we are thrilled to mark the completion of a long-term clinical study for Ivory graft, which developed Ivory Dentin Graft, for which we have participated for the past eight years.

Throughout this time, we managed the clinical trial, solved regulatory questions, and quality processes, leading to a significant milestone—CE approval for their Class III medical device!

This achievement is a testament to the multi-disciplinary impact Gsap brings to the industry. By integrating expertise across multiple domains, we accelerate innovation, reduce regulatory hurdles, and drive successful market entry for cutting-edge healthcare solutions.

This month, we are excited to announce the successful completion of the clinical study, which included the completion of 30 patients and obtained valuable insights.

Ivory Graft designed and developed the first porcine dentin xenograft. Ivory Dentin Graft™ is a dentin bone graft that retains the natural dentin form as well as the natural protein matrix and collagen, important for bone regeneration.

According to Amir, Ivory Graft CEO, “The Ivory Graft’s clinical results show superiority over porcine xenograft material, which is used in the dental industry today, due to the nature of dentin and its positive effect on bone growth.”

Partner with Gsap and experience the power of true end-to-end support. Our integrative approach—spanning clinical trial management, regulatory guidance, and quality assurance—ensures every milestone is met with precision and expertise. Let us help you accelerate innovation, overcome regulatory hurdles, and achieve outstanding execution for lasting impact in the healthcare industry.