Quality Management System (QMS) Support Services

Stay compliant and maintain high standards for your medical device, drug, or combination product.

Quality Management System (QMS) plays a critical role in the development of your medical product. We understand that QMS processes are key to your company's value, patient safety, and ensuring all products are high-quality.

Our flexible and hands-on approach is built for all sizes, from startups to well-established companies.

Engage

Whether you are establishing your first QMS or are looking for assistance with remediation, our quality experts are here to guide you through every step of the process.

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Our Approach QMS Support Services

Quality assurance at every step

From educational resources and support to detailed guidance to ensure you meet the necessary complex regulatory requirements, our experts provide QMS support tailored to your company's needs.

Extensive Expertise

Our team has years of experience in quality management and regulatory affairs, providing you with accurate and reliable guidance.

Hands-On Support

We are deeply involved in all aspects of QMS development, from initial planning to full implementation and ongoing audits.

Customized Solutions

We tailor our services to meet your specific needs, ensuring your QMS is robust, compliant, and efficient.

Quality Management System Services

Our Quality Management System (QMS) Support Services

QMS Development and Implementation

Tailored QMS Development:
We collaborate with your team to develop and implement a robust Quality Management System that meets all relevant regulatory standards.

SOP “Starter Pack” Support
Provision and customization of primary SOP templates, including Document Control, Design Controls, and Risk Management.

Internal Audits

Comprehensive Audits:
Our team conducts thorough internal audits to assess the effectiveness of your QMS, identify non-conformities, and provide actionable recommendations for continuous improvement.

CAPA Management

Corrective and Preventive Actions:
We assist you in developing and managing CAPAs to address any quality issues, helping you maintain a high level of quality and prevent future problems.

Training Programs

Customized Training:
We offer tailored training programs to educate your team on QMS processes and regulatory requirements, ensuring they are well-equipped to maintain compliance.

Remediation and Support

Establishing and Remediating QMS:
Whether you are establishing your first QMS or need help with remediation, we provide the support and expertise necessary to ensure your quality system is robust and compliant.

Fractional QA Management

Hands-On QA Management:
Our team can step in as fractional QA managers, providing hands-on involvement in various quality activities, including design control projects, quality sign-offs, and independent reviews.

Software Documentation

Regulatory Compliance:
We support the creation of software documentation to meet FDA requirements, ensuring a well-developed, verified, and validated product throughout its lifecycle.

QMS Internal Audit (21 CFR 820 & ISO 13485)

Performance and Efficiency Audits:
We measure the performance and efficiency of your QMS and identify gaps and potential non-compliances. We provide detailed audit reports with findings and recommendations.

QMS Gap Analysis (ISO 13485/21 CFR 820)

Comprehensive Gap Analysis:
We perform a thorough gap analysis to ensure your QMS meets ISO 13485 and 21 CFR 820 standards, providing recommendations for improvement.

QMS Assessment & Plan

Detailed Assessment and Planning:
Our QMS assessment includes a gap analysis and development of a comprehensive plan to ensure compliance with ISO 13485 and other relevant standards.

"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."

Position

First & Last Name

Position

First & Last Name

“Proxima has been such a wonderful help every step of the way. Everyone is truly great to work with.”

Junior Project Engineer

Karen Wells

We joined forces with Proxima's Quality Consultants to ready ourselves for upcoming audits of both our QMS and our parent company's QMS. Their approachable, expert team delivered essential support and insightful guidance, never shying away from directing us confidently towards the right path. We are proud to share our spotless ISO 13485 recertification audit, a testament to Proxima's steadfast commitment and fearless leadership!

Regulatory & QA Manager

Michael Selva

"Proxima has been attentive to a variety of our regulatory related needs. From coordinating studies with aggressive timelines to assisting with sales aid approvals, they have always delivered. As we launched our first in class/disease product, we needed a high touch clinical research and regulatory partner, and Proxima has provided that for us."

Founder & CEO

Robert Whitehead

Proxima has been an important piece of Memgen's regulatory and clinical achievements for multiple years now, playing a vital role in our IND approval, clinical launch, and trial management of our first-in-human study of our lead cancer immunotherapy biologic. Proxima and its growing team have continually shown their experience, broad skill sets, adaptability to our company's needs and objectives, and value in an industry with a myriad of CROs to choose from.

CSO

Mark Cantwell

Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.

Physician

Chester J. Koh, MD

"The wonderful people at Proxima have been dogged champions for our success. Aside from being deeply experienced in our particular field and keenly knowledgeable on developing trends they take our success as personally as we do. That, as much as anything, has been the difference."

COO & Co-Founder

Geoffrey Lucks

We have had the pleasure of working with the Proxima team for over a year on overall regulatory strategy and support for FDA interactions. The entire Proxima team are unbelievably knowledgeable in this space with excellent communication skills, highly strategic thinking, and amazing customer service. We at Prenosis highly recommend them as a one stop shop for anything regulatory or clinical trial related, all offered at a very attractive price point.

CEO and Co-Founder

Bobby Reddy Jr.

“As a busy surgeon developing a Class III implantable device I needed help with regulatory strategy and execution. I wanted someone that was as passionate about the device as I was and that could hit the ground running. Because PROXIMA supports emerging companies through Med Tech Innovator they were a perfect fit. Isabella also helped us manage other vendor relationships and kept things moving forward. I been very happy working with PROXIMA”

Founder

Marc Bessler, M.D.

Proxima was instrumental to our success in getting breakthrough device designation for our product! The team was very knowledgeable and responsive and set us up for success. They made the FDA process easy to go through and prepared us for future interactions with FDA.