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?

Look no further!

Our Post approval support Services

Adverse Event Monitoring

We assist in setting up a system to monitor and record adverse events related to your medical device products. This includes customer complaints, adverse reactions, and any safety concerns, ensuring that you can respond promptly.

Post-Market Surveillance Reporting

Our team helps in preparing and submitting necessary post-market surveillance reports to regulatory authorities as required. We ensure that your reports are accurate and comply with regulatory standards.

Product Quality Monitoring

We provide guidance on establishing quality control processes to monitor the consistency and quality of your medical device products in the market.

Corrective and Preventive Actions (CAPA)

In case of any product-related issues or non-compliance, we help you plan and implement corrective and preventive actions (CAPA) to address and prevent future problems.

Product Recalls and Withdrawals

If necessary, we assist in planning and executing product recalls or withdrawals in line with regulatory requirements to protect consumers and your brand's reputation.

Market Feedback Analysis

We analyze customer feedback and market trends to identify potential product improvements or modifications, helping you stay competitive and meet consumer expectations.

Regulatory Updates and Compliance

Our experts stay up-to-date with evolving medical device regulations and ensure your products remain compliant with current standards.

Customized Post-Market Surveillance Plans

We create tailored post-market surveillance plans to meet your specific product and market needs, ensuring you receive support designed for your unique situation.

Market Feedback Analysis

We analyze customer feedback and market trends to identify potential product improvements or modifications, helping you stay competitive and meet consumer expectations.

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

Read Here

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

Medical device single audit program (MDSAP) readiness audit
Risk management (ISO 14971)
Document control system implementation and remediation
quality system implementation
Quality system remediation
ISO 13485:2016
21 CFR part 820
Quality due diligence

Want to know more?

Let’s Talk

8563 +

Saticfied Custimer

263 +

Experience Team

Our Services

Our Compliance Assessment Process

1. Identifying the change

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.

2. Evaluating the impact of the change

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.

3. Determine the regulatory requirement

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.

4. Implementing the change

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.

5. Monitoring & evaluating the change

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.

6. Getting approval for the change

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

Request a Consultation

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!

Our New Product Approval Service Corner

We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) request, product classification, Q-submission and international registration.

Pre-submission Support

Before you even consider submitting a new product for regulatory approval, it is essential that you have a strategy in place for determining the best pathway to get clearances in one-go. The good thing with us is that we will have you prepared for all your regulatory inspections. Right from preparing and conducting pre-submission mock meetings, creating proper regulatory strategy to evaluating ISO 13485 & compliance for your product, we will help you throughout.

Associated Regulatory Authorities.

We’ve More
Then 2563+ Global Clients

Clients Testimonials

Amazing Feedback Say About Services

Tom Birney

CEO Masterlink, Arizona

^“ Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms _“

Diane Bryant

CEO Novasignal, Los Angeles

^“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process. _“

Daniel Kinsey

President ViDava, Florida

^“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice. _“

Linda Pan

Sr. Exe Treedental, Hong Kong

^“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step. _“

Joshua Mink

Manager Outset Medical, California

^“Highly recommend Elexes! They always meet commitments and follow through on action items. _“

Michal Depa

CTO Jana Care, Massachusetts

^“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly. _“

Philip McFerran

MD Blackrock Pharma, England

^“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations. _“

Samip Shah

VP Regulatory AliveCor, California

^“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise. _“

Elizabeth W

Owner Liz Inc., Arizona

^“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time. _“

Kurt Sysock

CEO Radformation, New York

^“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation! _“

Popular Clients

We’ve 200+ Global Premium Clients

Looking For Regulatory Assistance?

Let's Talk How We Can Help You?

Latest News & Blog

Read Our Latest Articles

Technological Changes that Call for a New 510k Submission

October 7, 2024 Comments Off