Our Professional Medical Device Services

Comprehensive and Customized Solutions for Every Regulatory and Technical Challenge

Professional Management of NPI Processes in Medical Devices

As experts in NPI for medical devices, we lead all stages of the New Product Introduction process from start to finish.

מומחי תחום בשיתוף פעולה  
מלווה את הפיתוח הטכני, מנהל את התיעוד הרגולטורי, ומבטיח עמידה בכל הדרישות של רשויות הבריאות הבינלאומיות כולל FDA, CE ו-PMDA.

Our process includes comprehensive risk analysis, regulatory strategy planning, professional project management, and close guidance throughout the entire product lifecycle. We understand that each product is unique, so we tailor our approach to the specific needs of each client.

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Obtaining Regulatory Approvals for Design Changes in Medical Devices

As an expert in obtaining regulatory approvals for design changes in medical devices, we confidently navigate the complex requirements of various health authorities. Whether dealing with minor or significant changes to existing products, we ensure the process is conducted quickly, efficiently, and with a high probability of approval.

Our service includes preliminary assessment of the requested change, determining the required regulatory classification (510k, PMA, CE amendment, etc.), preparing complete documentation, coordinating with regulators, and guidance until final approval is obtained. We work with authorities worldwide and have in-depth knowledge of different requirements.

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Leading Implementation of PLM Documentation and Change Management Systems

Leading implementation of PLM documentation and change management systems is one of our core specialties. We understand that an efficient PLM (Product Lifecycle Management) system is the heart of every successful medical device organization, which is why we specialize in selecting, customizing, and implementing these systems.

Our process includes organizational needs analysis, selecting the most suitable system, adapting the system to existing workflows, defining work processes and controls, user training, and post-implementation support. We work with all leading systems in the market and ensure full integration with existing organizational systems.

PLM Systems Implementation - System Interface

Smooth Transfer from Development to Manufacturing in Medical Device Systems

As an expert in transfer from development to manufacturing in medical device systems, we specialize in creating an efficient bridge between the development stage and commercial manufacturing stage. Our process ensures that the product developed in the lab can transition to large-scale production while maintaining quality, standards compliance, and economic efficiency.

The service includes preparing DMR (Device Master Record) documentation, developing controlled manufacturing processes, validation of equipment and materials, training manufacturing teams, and conducting comprehensive testing and validation. We guide your team at every stage and ensure a smooth transition without delays.

Transfer from Development to Manufacturing - Manufacturing Processes

Interested in Learning More About Our Services?

Contact us today for an initial consultation call with no obligation. We'd be happy to learn about your challenges and offer tailored solutions.

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