WHO WE ARE
Common Sense has been providing regulatory affairs and compliance engineering services to the medical device industry since 2008.
Located in Kirkland, WA, our team includes professionals with decades of relevant medical device development experience.
OUR EXPERTISE
We specialize in a wide range of regulatory standards and processes, including:
- ISO 14971 (Risk Management)
- ISO 13485 (Quality Management Systems)
- IEC 60601 (Medical Electrical Equipment)
- IEC 62304 (Medical Device Software)
OUR SERVICES
Common Sense Systems, Inc. offers comprehensive regulatory affairs services to ensure your medical devices meet all necessary compliance requirements:
Procedure Development
Our procedure development service helps you establish robust, compliant processes tailored to your specific medical device and organizational needs. We work closely with your team to create clear, effective, and regulatorily compliant procedures that streamline your operations and ensure consistency across your organization.
By leveraging our expertise, you’ll benefit from:
- Procedures aligned with current regulatory requirements
- Improved operational efficiency and reduced errors
- Enhanced traceability and auditability
- Easier employee training and onboarding
Verification and Validation Plans
We assist in developing comprehensive verification and validation (V&V) plans that demonstrate your medical device’s safety, effectiveness, and compliance with regulatory requirements. Our approach ensures that your V&V activities are thorough, well-documented, and aligned with regulatory expectations.
Benefits of our V&V planning service include:
- Reduced risk of regulatory delays or rejections
- Improved product quality and reliability
- Efficient use of resources during the V&V process
- Enhanced confidence in your device’s performance and safety
Compliance Engineering
Our compliance engineering service helps you navigate the complex landscape of medical device regulations. We work with your engineering team to integrate compliance considerations throughout the product development lifecycle, ensuring that your devices meet all applicable standards and regulations.
By choosing our compliance engineering service, you’ll gain:
- Early identification and mitigation of potential compliance issues
- Streamlined product development process
- Reduced time-to-market and development costs
- Increased likelihood of successful regulatory submissions
Corrective and Preventive Actions (CAPAs)
We help you establish and maintain an effective CAPA system that not only meets regulatory requirements but also drives continuous improvement in your organization. Our approach focuses on root cause analysis, implementing effective solutions, and preventing recurrence of issues.
The benefits of our CAPA service include:
- Improved product quality and patient safety
- Enhanced regulatory compliance
- Reduced risk of repeat issues and associated costs
- Streamlined quality management processes
Regulatory Strategy and Submission Support
Our team provides expert guidance in developing regulatory strategies and preparing submission documents for various markets. We help you navigate the complex regulatory landscape, ensuring that your submissions are complete, accurate, and aligned with the latest regulatory requirements.
Choosing our regulatory strategy and submission support service offers:
- Optimized regulatory pathways for your devices
- Higher quality submissions with increased likelihood of approval
- Reduced time and resources spent on regulatory processes
- Expert guidance throughout the submission and review process
Quality Management System Implementation and Maintenance
We assist in implementing and maintaining robust quality management systems (QMS) that comply with ISO 13485 and other relevant standards. Our approach ensures that your QMS is not just compliant, but also efficient and tailored to your organization’s needs.
Benefits of our QMS service include:
- Improved product quality and consistency
- Enhanced regulatory compliance across markets
- Increased operational efficiency and reduced waste
- Better preparedness for audits and inspections
Risk Management
Our risk management service helps you implement and maintain a comprehensive risk management process in line with ISO 14971. We work with your team to identify, analyze, evaluate, and mitigate risks associated with your medical devices throughout their lifecycle.
By leveraging our risk management expertise, you’ll benefit from:
- Improved product safety and effectiveness
- Enhanced regulatory compliance
- Reduced likelihood of post-market issues and recalls
- Better informed decision-making in product development
Software Lifecycle Processes
We provide guidance and support in implementing compliant software lifecycle processes in accordance with IEC 62304. Our service covers all aspects of medical device software development, from planning and requirements analysis to implementation, verification, and maintenance.
Choosing our software lifecycle process service offers:
- Improved software quality and reliability
- Enhanced compliance with software-specific regulations
- Streamlined software development processes
- Reduced risk of software-related issues and recalls
WHY CHOOSE US
- In-depth industry experience
- Expert knowledge of key medical device standards
- Tailored solutions to meet your specific needs
- Commitment to quality and compliance
HOW TO REACH US
Ready to ensure your medical devices meet all regulatory requirements? Contact us today to discuss how we can support your regulatory affairs needs.