Supporting Medical Device Startups for Success

Welcome to Safetek Regulatory Services! We specialize in guiding medical device startups to success with tailored support and expertise.

Hardware and Software Design and Development

Leverage our experienced team of engineers to develop cutting-edge hardware and software solutions for your medical devices. Benefit from our deep understanding of the industry standards and regulations to ensure compliance and optimize performance.

Regulatory Compliance

Navigate the complex landscape of regulatory requirements with confidence. Our regulatory experts will assist you in understanding and meeting the necessary compliance standards, including FDA regulations, ISO certifications, and other regional requirements.

Testing Support

Access our state-of-the-art testing facilities and collaborate with our skilled technicians to conduct comprehensive tests and validations for your medical devices. Ensure the safety, reliability, and effectiveness of your products through rigorous testing protocols.

Supplier Development

Forge strong partnerships with reliable suppliers through our supplier development program. Benefit from our extensive network of trusted suppliers, negotiate favorable contracts, and establish robust supply chains.


Equip your team with the knowledge and skills required for success in the medical device industry. Our customized training programs cover a wide range of topics, including regulatory compliance, quality management systems, and best practices in medical device development.

Consultancy on Quality Management Systems

Streamline your operations and ensure quality throughout your organization. Our experts will guide you in implementing effective quality management systems, such as ISO 13485, to enhance efficiency and product excellence.

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