Post Approval Support

Once your medical device is approved, there comes the challenge where you have to continuously keep monitoring the safety and effectiveness of the device. With the ever-changing world of regulatory and compliance rules, it is critical that you have someone to keep a check on it and ensure that your device is up to date with all the compliance requirements.

With our team at your side, you can stop worrying about this. We will have a dedicated person to monitor the safety and compliance requirements, perform proper medical device reporting as applicable, for your device to remain in the market without any risks.

Looking for new product approval support?

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Our Post approval support Services

Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

Our post approval compliance assurance process

- Strategic leadership and management of the QA/RA functional area - Staff transitions or augmentation - Special projects lacking internal bandwidth - Early stage companies looking for strategic insights for QA/RA.

Additional quality support services include

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Our Services

Product Quality Monitoring

Product Quality Monitoring

We provide guidance on establishing quality control processes to monitor the consistency…

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Corrective and Preventive Actions (CAPA)

Corrective and Preventive Actions (CAPA)

In case of any product-related issues or non-compliance, we help you plan…

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Customized Post-Market Surveillance Plans

Customized Post-Market Surveillance Plans

We create tailored post-market surveillance plans to meet your specific product and…

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Product Recalls and Withdrawals

Product Recalls and Withdrawals

If necessary, we assist in planning and executing product recalls or withdrawals…

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Market Feedback Analysis

Market Feedback Analysis

We analyze customer feedback and market trends to identify potential product improvements…

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Regulatory Updates and Compliance

Regulatory Updates and Compliance

Our experts stay up-to-date with evolving cosmetic regulations and ensure your products…

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Post-Market Surveillance Reporting

Post-Market Surveillance Reporting

Our team helps in preparing and submitting necessary post-market surveillance reports to…

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Our Compliance Assessment Process

We, first identify the change that is being proposed post approval of the medical device. This includes evaluating changes to the device’s design, manufacturing process, labeling, and usage.

The next step in the process is to evaluate the impact of the indentified change on both the safety and efficacy of the medical device. This step involves conducting risk assessments, testing, determining the potential impact of the change.

Depending on the type of change and regulatory framework in which device is marketed, the plan for the post approval regulatory clearance is created and implemented.

Once the change has been evaluated and approved, we then implement the change in a controlled manner which often involve updating the device’s design, manufacturing process, labeling, as well as usage instructions.

After implementing the change, we help you monitor and evaluate its impact on the safety as well as efficacy of the medical device. At this step, we will collect and analyze the data on the performance of the device and conducting risk assessment and testing regularly.

At the final step, we help medical device manufacturer report the change to the relevant regulatory body as per the set regulatory framework.

If you are looking for a post-approval support for your medical device, all you have to do is

Compliance Assurance

Stay compliant with industry regulations and standards.

Cost-effective

Achieve regulatory success with Elexes, all within your budget.

Why choose

Elexes for medical device regulatory & compliance services?

Quick Turn around

Experience timely results with our efficient services.

Confidentiality guaranteed

We offer 100% confidentiality understanding how critical the data is for you.

Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!

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