Regulatory compliance for Medical Device Regulation 

Decos is your trusted partner in ensuring global regulatory compliance for your medical devices. Our experienced team provides a comprehensive suite of services to guide your products from concept to market.

Our Expertise:

• Device Documentation:
  • Streamline your product development process with our expert documentation services.
  • Ensure regulatory compliance and market access with precise and accurate documentation.
• Labeling:
  • Deliver comprehensive labeling solutions tailored to your specific needs.
  • From initial concept to final artwork, we guide you through the entire labeling process.
• Regulatory and Technical Writing:
  • Our skilled technical writers create clear and concise documentation that meets global regulatory standards.
  • We specialize in a wide range of medical device documentation, including STEDs, CERs, PSURs, UOUPs, user manuals, and more.

Expert QMS Solutions

A robust Quality Management System (QMS) is the cornerstone of medical device excellence. At Decos, we provide comprehensive QMS solutions tailored to your specific needs, ensuring compliance with ISO 13485 and other relevant regulatory standards.

Our QMS Services:

• Strategic QMS Development: We design and implement a QMS that aligns with your business objectives and regulatory requirements.
• Market-Specific Compliance: We identify and address the unique QMS needs of your target markets.
• Comprehensive Documentation: We create essential QMS documentation, including SOPs, work instructions, quality policies, manuals, and design control procedures.
• Regulatory Readiness: We prepare your organization for successful internal, mock, supplier audits, and audits from notified bodies.
• Expert Training: We empower your team with QMS training to ensure compliance and operational excellence

Country Specific Regulatory and Quality Compliance

Medical device manufacturers must navigate diverse country-specific regulations to ensure global market access. Each nation has its own regulatory body, like the FDA (U.S.) or EMA (Europe), with distinct standards for approval, QMS (ISO 13485), and post-market surveillance. Differences in clinical evaluation, labeling, language, and cybersecurity require tailored strategies. Additionally, data protection laws such as HIPAA, GDPR, LGPD, APPI, PIPL, and DPDP must be considered for compliance.

Our Services:

• Conduct a Compliance Gap Assessment: We will analyze the existing processes and systems to identify gaps in compliance with relevant regulations (HIPAA, GDPR, MDR, etc.).
• Prioritize and Develop a Remediation Plan: We will work to prioritize the identified gaps and develop a phased remediation plan, focusing on the most critical areas first.
• Integrate Compliance into Existing Processes: Our goal is to integrate compliance into the existing innovation processes rather than creating separate, burdensome systems. It might involve adapting the client’s development lifecycle, data management practices, or risk management framework.
• Provide Training and Support: We will provide training and support to ensure that teams understand their compliance obligations and how to implement them effectively.
• Ongoing Monitoring and Updates: We can assist with setting up ongoing monitoring processes to ensure continued compliance and provide updates on any changes in the regulatory landscape.