Outsourced Quality Support

Outsourced quality and regulatory management is one of the most common practice when it comes to medical device industry. The quality assurance & regulatory affairs functions can be very complex to manage for different products. This is why medical device manufacturers look for outsourced quality support to manage operations and regulatory practices.

There are several things that medical device manufacturers need to understand at the primary stage of their product life cycle like product filings, regulatory pathway, manufactureing setup, as well as quality management systems creation.

You can check our QMS setup and implementation services here

QMS Setup & Implementation (ISO 13485, 9001, 9000)

Our New Product Approval Service Corner

We offer different services that will help you not only keep your product well within the 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) requests, 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.

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

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Apart from the QMS setup and remediation, we offer several other services including:

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

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Saticfied Custimer

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Experience Team

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

Our Services

Our Compliance Assessment Process

Initial Consultation

Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.

Regulatory Expertise

Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.

Document Review

We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Gap Analysis

Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.

Recommendations

Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.

Ongoing Support

Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.

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!

Looking for someone who can assist you

to build a compliant quality management system for your medical device company

Request a Consultation

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

Associated Regulatory Authorities.

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Then 256+ Global Clients

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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! _“

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Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies

December 4, 2024 Post a Comment