Design Controls and Risk Management

Streamlined Design Controls and Risk Management

ADBC CRO ensures compliance with regulatory standards by integrating design controls and risk management into your product development process. We focus on quality, safety, and performance to deliver innovative medical devices that meet global regulatory requirements.

Design controls and risk management are essential parts of developing medical devices, ensuring that products not only meet the highest standards but also in terms of safety, efficacy, and compliance with regulatory requirements. ADBC CRO offers end-to-end support to help you implement robust design control processes while managing risks through the entire product lifecycle.

ADBC CRO: The Partner for the Management of Design Controls and Risks

  • Full-Product-Development Support
    With its extensive expertise in all product-development phases, ADBC CRO delivers integrated design-control and risk-management solutions for comprehensive regulatory compliance support.
  • Anticipatory Identification of Risk
    Our team is best at identifying potential risks early in the design process, allowing you to get to issues before they become costly or compromise product safety.
  • Global Compliance Mastery
    We ensure that your design and risk processes meet the stringent requirements of FDA, ISO 13485, ISO 14971, and other international regulatory frameworks, keeping you prepared for audits and submissions.
  • Tailored Risk Management Strategies
    We recognize that every product is unique, and we create strategies that target specific risks in the best interest of your business objectives and compliance requirements.
  • Streamlined Documentation Processes
    We make creating and maintaining critical design documents like the Design History File (DHF) and Risk Management File (RMF) less complicated so that your compliance journey will be smooth.
  • Expert Guidance for Regulatory Challenges
    The consultants in ADBC CRO have all the experience and deliver actionable insights and strategies to enable the overcoming of regulatory barriers for ensuring that your medical device reaches the market without delay.
  • Innovation and Safety Pledge
    We help in the designing of medical devices offering safety and performance outcomes by introducing innovation and a patient-centric process in our systems.

Design Controls and Risk Management Services

Comprehensive Design Control Implementation We help set up and maintain design control processes. We start from establishing input and output documentation and work through verification, validation, and design transfer activities.
Risk Management Planning Our experts assist you in developing detailed risk management plans that are aligned with ISO 14971 to identify, assess, and mitigate risks at every stage of product development.
Hazard Analysis and Risk Assessment Hazard analysis and risk assessments are conducted to identify potential failure modes and implement strategies for risk reduction and control.
Design History File (DHF) Management We document all design activities in the DHF to demonstrate compliance with regulatory requirements during audits or submissions.
Failure Mode and Effects Analysis (FMEA) We use FMEA to systematically identify and address potential failures to ensure the reliability and safety of your product.
Post-Market Risk Management After development, we help in monitoring and updating risk management files based on real-world performance and post-market data.
Training and Consulting Services We train your staff through tailor-made training and offer consulting to equip them with all knowledge and tools to enforce good design controls and effective risk management.

Partner with ADBC CRO for seamless, compliant device development!

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Global Impact

Our mission extends beyond delivering products and services; we are dedicated to making a lasting positive impact across the globe. Through our commitment to excellence in customer service, product innovation, and regulatory compliance, we drive sustainable growth, foster trust, and set new standards within our industry. Each initiative is part of our vision to empower communities, support industries, and contribute meaningfully to a better world.

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