Elexes Team 
Team Elexes 
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
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.
- 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
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Our Services
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!
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 -
Associated Regulatory Authorities.
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.
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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!
“
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