Post Market Surveillance

Did you know that deficiencies with Post Market Surveillance (PMS) and Complaint Handling are the most frequent inspections and warning letter citations? A company has the potential to receive a large number of complaints daily, each of which must be handled per an established process with strategic action. Global regulation requires assessment and report of adverse events associated with their products in a timely manner. Manufacturers must commit to monitoring any new medical device or drug product released into the market, and ECI can assist with due diligence.

ECI has effectively managed PMS projects ranging from five resources to upwards of 120+ resources to compliantly satisfy regulatory requirements. These projects ranged from effectively addressing a backlog of complaints to ensuring proper reportability decisions were being made to the way to implementing a fully remediated PMS system. Whether your organization has self-identified a deficiency within your PMS system or you’ve received an FDA or other regulatory body finding, ECI will support your organization with a quickly-scalable and expert team to these needs.

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Our Approach to Post Market Surveillance & Resource Management

Clear Strategy Development

Our team will clearly assess your current processes, identify deficiencies, and define the ultimate scope and goal of the project.

Communication & Change Management

ECI will develop the required communication, strategy, and quality planning tools necessary to ensure clear and concise messaging across the organization.

Post-Remediation Evaluation

ECI will provide a roadmap and training to ensure your internal resources are able to uphold newly-implemented processes to build off the foundation provided.

Executing Activites

ECI will review your current processes/system against regulatory (and any other requested) requirements and determine a remediation plan. Scalable execution will prioritize the highest risk items to the organization.

Regulatory Consultation

Our team of experts provides personalized regulatory consultation services tailored to your specific needs. We help you understand the implications of IVDR on your products and guide you through the regulatory landscape.

Product Assessment & Classification

Ensure accurate product classification under IVDR guidelines. We conduct thorough assessments of your in vitro diagnostic products, aiding in their proper classification and determining the necessary conformity assessment procedures.

Technical Documentation Review & Enhancement

Prepare and review technical documentation to meet IVDR standards. We assist in compiling, reviewing, and enhancing technical files, ensuring they align with the regulatory requirements for successful conformity assessment.

Quality Management System (QMS) Implementation

Implement a robust Quality Management System aligned with IVDR standards. Our consultants work with you to establish and enhance your QMS, ensuring it meets the stringent requirements outlined in the regulation.

Post-Market Surveillance Support

Stay vigilant with our post-market surveillance support. We help you establish and maintain effective processes for monitoring and reporting the performance of your in vitro diagnostic devices in the market.

The Benefits of ECI Solutions

Specialized Expertise

Support from former FDA staff and subject matter experts with thorough knowledge of the regulatory environment.

Independent & Unbiased Third-Party Guidance

ECI offers objective and impartial advice, essential for maintaining compliance and making informed decisions without internal biases. This guidance helps ensure regulatory adherence and credibility in project execution.

Temporary Needs & Flexibility

ECI can provide the right team member at the right stage of the project. Whether you need experts to assess information, formulate FDA responses, or create systemic remediation plans, or executors to complete deliverables, our team will assign the right resource to your project.

Speed of Implementation

In most cases, ECI can start working on your project right away. This speed of service is crucial when it comes to responding appropriately to the FDA, implementing robust remediation plans, and ensuring that progress aligns with communicated timelines.

Knowledge Transfer

Our team ensures smooth knowledge transfer and best practices for internal teams during their engagement. This serves to enhance the capabilities of the existing workforce, leaving a positive impact long after our team has completed their assignment.

Focus on Core Competencies

Hiring ECI allows your internal team to focus on their core competencies and daily responsibilities, which can lead to increased efficiency and productivity within your organization.

Impact That’s Tangible

Want to see how ECI supports clients after their products go to market? Through the following case studies, learn how our team has helped other customers as they navigate post market surveillance.

VIEW ALL CASE STudies

Post Market Surveillance

Our Approach to Post Market Surveillance & Resource Management

The Benefits of ECI Solutions

Specialized Expertise

Independent & Unbiased Third-Party Guidance

Temporary Needs & Flexibility

Speed of Implementation

Knowledge Transfer

Focus on Core Competencies

Impact That’s Tangible

Post Market Surveillance & Vigilance Case Study

Post Market Surveillance & Vigilance Case Study

Post Market Surveillance & Vigilance Case Study

Technology Transfer Case Study

Technology Transfer Case Study

Technology Transfer Case Study

Our Strategic Services

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Our Strategic Solutions

FDA Warning Letter

EU MDR

IVDR

Regulation Strategy & Submissions

Technology Transfer

Post Market & Resources Management

Merger & Acquisitions and Due Diligence & Integrations Solutions