Medical Device

Streamline Medical Device and Lifescience Development through Regulatory Compliant Solutions

Introducing Orcanos Compliance Solution, the comprehensive platform designed to accelerate medical device and life science development while ensuring regulatory compliance. Our solution caters to the unique needs of industries such as biotech, pharma, combination products, diagnostics, medical device data systems (MDDS), and more.

Orcanos offers a powerful solution that seamlessly integrates Application Lifecycle Management (ALM) with Quality Management Systems (QMS). By connecting ALM with QMS, you can achieve remarkable efficiency gains and cost savings while ensuring regulatory compliance.

Streamlined Design Controls and Regulatory Compliance

Our platform streamlines the entire product development lifecycle, enabling efficient management of requirements, design controls, risk assessments, and regulatory submissions. By centralizing these processes, Orcanos eliminates redundancies, reduces errors, and accelerates time-to-market.

Aligned with Key Standards and Regulations

We understand the importance of adhering to industry standards and regulations in the life science space. Orcanos Compliance Solution aligns with essential medical device frameworks and regulations, including ISO 13485 for quality management, ISO 14971 for risk management, IEC 62304 for medical device lifecycle requirements, FDA regulations such as 21 CFR 820.30 and CFR Part 11, and EU medical device directives and regulations. By leveraging our solution, you can confidently navigate regulatory landscapes.

Software as a Medical Device (SaMD) Support

In the evolving landscape of digital health, software plays a critical role. Orcanos Compliance Solution recognizes the significance of Software as a Medical Device (SaMD) and supports its principles. With our platform, you can ensure the safety, effectiveness, and performance of clinical web and mobile software applications. We align with SaMD guidance adopted by regulatory leaders worldwide, providing a robust framework for compliance.

– Import/Export Office Documents with Ease

With Orcanos Compliance Solution, you can seamlessly import and export office documents, allowing for smooth integration with your existing workflows. Easily incorporate documentation such as design files, test protocols, and risk assessments, ensuring comprehensive coverage and efficient collaboration.

– Support for Any Existing Methodology

We recognize that different organizations may follow different methodologies. With Orcanos, there’s no need to change your current processes. Our solution supports any existing methodology, allowing you to continue working in a way that best suits your team and projects.

– Compliance and Agile Tool Integration

Orcanos acts as your watchdog for compliance. It seamlessly integrates with popular Agile tools like Jira, providing you with a “Fast Lane” for streamlined development. Enjoy the benefits of Agile methodologies while maintaining compliance with regulatory standards.

– Full Traceability and Comprehensive Support

Orcanos Compliance Solution provides full traceability throughout the development process. From requirements management to testing, defect tracking, and risk management, our platform ensures that all activities are documented and linked, enabling complete traceability for audits and compliance purposes.

Key Benefits of Orcanos Compliance:

  1. Efficient Design Controls: Streamline design control processes, including requirements management, risk assessments, and regulatory submissions, saving time and improving collaboration.

  2. Regulatory Compliance Made Easy: Simplify compliance with industry standards and regulations, ensuring adherence to ISO standards, FDA regulations, and EU directives.

  3. Accelerated Time to Market: By streamlining workflows and automating processes, Orcanos Compliance Solution helps you bring products to market faster, gaining a competitive advantage.

  4. SaMD Support: Leverage our platform to meet SaMD requirements, ensuring safety, effectiveness, and performance of software applications in the medical device and life science space.