Software and Firmware Development

Your Trusted Partner in Medical Device Compliance. From Certification Support to MDSAP Consultancy and Testing, Safetek Ensures Quality and Regulatory Compliance Worldwide.

What type of development we support?

Development Support for Electromedical Device Hardware and Accessories
Development Support on Implants
Software and Firmware Development for Medical Devices

Types of Development Support

Certification Support

Certification is a crucial step in bringing your electromedical devices and accessories to market. Our experienced consultants provide comprehensive certification support, guiding you through the certification processes specific to Brazil, Japan, USA, Australia, and Canada. We assist in preparing the necessary documentation, conducting gap assessments, and facilitating communication with regulatory authorities to ensure a smooth certification journey.

Regulatory Compliance Guidance

Developing electromedical device hardware and accessories requires compliance with regulatory standards and guidelines. Our team of regulatory experts will guide you in understanding and meeting the applicable regulatory requirements specific to each region. We ensure compliance with relevant standards such as the IEC 60601 series, helping you navigate the complex landscape of medical device regulations.

MDSAP Consultancy

If you aim to target multiple international markets, our MDSAP consultancy services are tailored to meet your needs. We specialize in Medical Device Single Audit Program (MDSAP) requirements, which streamline the audit process and facilitate certifications accepted by multiple regulatory authorities. We guide you through MDSAP implementation, ensuring compliance across Brazil, Japan, USA, Australia, and Canada.

Safety and Biocompatibility Testing

The safety and biocompatibility of electromedical devices and accessories are paramount. We offer comprehensive testing services to assess the safety, performance, and compatibility of your hardware and accessories with the intended use and users. Our experts perform a range of tests, including electrical safety testing, EMC testing, usability testing, and biocompatibility testing, ensuring that your products meet the highest safety standards.

Design and Development Support

Our team provides valuable guidance throughout the design and development process of electromedical device hardware and accessories. We assist you in implementing design control procedures, ensuring compliance with relevant standards and regulations. Our experts offer support in risk management, verification and validation activities, and usability engineering, helping you develop high-quality, safe, and effective products.

Quality Assurance and Documentation

Establishing robust quality assurance processes and comprehensive documentation is vital for the successful development of electromedical devices and accessories. Our consultants assist you in developing and implementing quality management systems aligned with industry best practices and regulatory requirements. We guide you in generating the necessary technical documentation, including design history files (DHF) and technical files, to support regulatory submissions.

Risk Management

Implantable devices involve inherent risks that must be effectively managed to ensure patient safety. Our consultants assist you in developing robust risk management strategies tailored to your implantable devices. We help you identify potential risks, implement risk control measures, and establish risk mitigation plans, ensuring that your devices are designed and manufactured with patient safety as a top priority.

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