Standard Operating Procedures (SOP) are crucial for medical software manufacturers, since they:
- ensure consistency, standardization and efficiency in processes, which helps maintain a high level of quality in the design and development of medical software preventing errors, defects, and deviations that could compromise the safety and efficacy of the product.
- provide a documented framework for compliance with medical device regulations, ensuring and demonstrating that the manufacturer meets all the necessary requirements.
- help transfer knowledge and expertise within the organization, ensuring that best practices are consistently applied and maintained even as personnel changes occur.
- play a critical role in risk management by defining procedures for hazard identification, risk assessment, and risk mitigation throughout the product lifecycle.
- provide a baseline for process evaluation and continuous improvement to adapt to evolving regulations, industry standards, and best practices.
Our team of seasoned professionals brings in-depth knowledge and extensive experience in creating SOPs that align with the applicable rigorous regulations and standards, such as:
- EU MDR (2017/745)
- FDA 21 CFR Part 820
- Swiss MedDO
- ISO 13485
- ISO 14971
- ISO 62366
- IEC 62304
- IEC 82304-1
- AAMI TIR 45
- ISO 15223-1
- ISO 20417
To unlock the power of regulatory and quality compliance we combine our deep understanding of the requirements with a customized approach to develop SOPs that reflect the gold standard in the medical device industry and are designed to:
- implement easy to follow procedure and efficient documentation
- enable your team to navigate the complex landscape of medical software development, from requirements gathering to validation to maintenance
- optimize your operations and ensure compliance with regulatory requirements
- prioritize usability engineering to ensure and enhance quality, safety and effectiveness of your medical software
- establish a systematic and comprehensive approach to identify, evaluate, and mitigate risks throughout the product life cycle
- implement accurate and compliant medical software labeling including the use of graphical symbols and unique device identifiers
- meet the unique challenges and objectives of your organization
Our comprehensive service will equip your organization with the tools and procedures necessary to achieve regulatory compliance, enhance product quality, and safeguard patient well-being.
Contact us today to learn more about our SOP development services.
