Events

RQMIS will be exhibiting at Medica Trade Fair 2024 in Dusseldorf, Germany from November 11-14, 2024

We are thrilled to announce that RQMIS will be exhibiting at the MEDICA 2024 Conference in Düsseldorf, Germany! Join us from November 11th-14th in Hall 16, Booth 15G24-1 to discover how we help medical device, pharmaceutical, nutraceutical, and cosmetic companies navigate complex regulatory, clinical, quality, insurance reimbursement, and cybersecurity challenges.

Looking forward to connecting with global industry leaders and sharing insights that drive innovation in healthcare.

Here’s a LinkedIn invitation you can use for RQMIS's Lunch and Learn event: Join Us for a MedTech Lunch and Learn at M2D2!

RQMIS is excited to invite you to our Lunch and Learn session on October 2, 2024, from 12:00 PM - 1:30 PM at M2D2 at UMass Lowell. This Part 1 of a 2 Part series.

This event will focus on MedTech Regulatory Considerations, providing valuable insights into navigating the complex regulatory pathways for medical device companies. Topics will include:

• Regulatory Pathways
• Pre-Submission Best Practices
• Insurance Reimbursement Strategies
• Quality Management System (QMS) Consulting

Our expert consultants will guide you through the critical steps to ensure compliance and streamline your product development process.

Date: October 2, 2024
Time: 12:00 PM - 1:30 PM
Location: M2D2 at UMass Lowell

https://www.eventbrite.com/e/m...

RSVP today and secure your spot for this engaging and informative session. Lunch will be provided!

Join us September 11 for the MTEC M-Corps Showcase Webinar with RQMIS: "Navigating the Regulatory Application Process for Medical Products.”

Date: Wednesday, September 11, at 1PM-2PM ET

Description

In today’s rapidly evolving healthcare landscape, successfully navigating the complex regulatory environment is critical to bringing your medical products to market. This Webinar will provide you with a comprehensive overview of the key regulatory pathways, the integration of clinical evidence, quality management systems, cybersecurity considerations, and insurance reimbursement strategies. Led by Barry Sands, President and Founder of RQMIS, this session is designed to equip you with the knowledge and strategies needed to streamline your regulatory journey and ensure your product meets all necessary requirements for approval.

Speaker: Barry Sands, President and Founder, RQMIS

Register at:

https://ati.zoomgov.com/meeting/register/vJIscOCtrTkpGaNgkkC-arKliaY2UVgHpeM

**You must be current MTEC Member in good standing in order to attend**

RQMIS Joins M-Corps to Enhance Support for Medical Product Development

Amesbury, MA – July 17, 2024 – RQMIS, Inc., a premier consulting firm specializing in regulatory, clinical, quality, and cybersecurity services, is proud to announce its membership in M-Corps, a distinguished component of the Medical Technology Enterprise Consortium (MTEC). This collaboration marks a significant step in RQMIS’s mission to support and advance medical product development by providing expert guidance to MTEC members.

M-Corps is an exclusive network of trusted subject matter experts and service providers dedicated to assisting MTEC members with the complex business, technical, and regulatory challenges inherent in the medical product development process. As a member of M-Corps, RQMIS will leverage its extensive experience and industry knowledge to deliver tailored consulting services that facilitate innovation and compliance.

About RQMIS

RQMIS offers a comprehensive suite of services to the global medical device, pharmaceutical, nutraceutical, and cosmetic industries, including:

• Regulatory Consulting: Expertise in regulatory submissions, strategic planning, and compliance with international regulations.
  
• Clinical Consulting: Design and management of clinical trials, development of clinical evaluation reports, and post-market surveillance.
  
• Quality Management: Implementation and optimization of Quality Management Systems, audit preparation, and CAPA plans.
  
• Cybersecurity: Risk assessments, implementation of cybersecurity measures, and compliance with data protection regulations.

Commitment to Excellence

“Our membership in M-Corps is a testament to RQMIS’s dedication to supporting the development of innovative medical products,” said Barry Sands, President and Founder of RQMIS. “We are honored to join this esteemed group of experts and look forward to collaborating with MTEC members to navigate the intricacies of regulatory compliance and product development.”

About MTEC and M-Corps

The Medical Technology Enterprise Consortium (MTEC) is a non-profit organization that aims to accelerate the development of medical technologies to improve healthcare outcomes for military personnel and civilians. M-Corps, a component of MTEC, comprises select trusted experts and service providers poised to assist MTEC members in navigating the business, technical, and regulatory intricacies of medical product development.

Looking Forward

By joining M-Corps, RQMIS is poised to provide unparalleled support to MTEC members, helping them achieve their goals of bringing safe, effective, and innovative medical products to market. This partnership underscores RQMIS’s commitment to excellence and its ongoing effort to drive advancements in the medical product industry.

For more information about RQMIS and its services, please visit https://rqmis.com/ or contact fmanning@rqmis.com.

Contact:

Frank Manning
Business Development Manager
RQMIS, Inc.
978-358-7307
frankmanning@rqmis.com
https://rqmis.com

About RQMIS, Inc.:
RQMIS, Inc. is a leading consulting firm that provides regulatory, clinical, quality, and cybersecurity services to the global medical device, pharmaceutical, nutraceutical, and cosmetic industries. With a commitment to excellence and a deep understanding of the regulatory landscape, RQMIS helps companies navigate complex challenges and achieve compliance, ensuring their products meet the highest standards of safety and efficacy.

About MTEC:
The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC). MTEC’s goal is to accelerate the development of medical solutions that prevent and treat injuries and restore health to U.S. service members and civilians.

RQMIS and Twin Tech Labs Announce Joint Partnership

Boston, June 26, 2023

RQMIS, Inc. and Twin Tech Labs are pleased to announce a new partnership to bring cybersecurity testing and monitoring to the ever-expanding market of software-based medical products and their associated network and cloud-based platforms. FDA’s recent publications and guidance regarding premarket and post market requirements for cybersecurity testing and monitoring of medical devices have significantly expanded the regulatory threshold for a pathway to market. Twin Tech Labs brings to the table decades of experience in IoT, machine learning, and cybersecurity, including leveraging best-in-class open-source components and frameworks to secure digital assets.

Positive Customer Impact

RQMIS clients have already benefited from the ongoing guidance and penetration testing by Twin Tech Labs. One of our clients has developed a medical device designed to help manage emergency triage by determining the likelihood of internal hemorrhage after connecting wirelessly to patient monitoring equipment. Their device was subjected to cybersecurity penetration testing which demonstrated the secure environment created by the device. Another RQMIS client is designing a smartphone-based defibrillator with interfaces to the emergency phone system and cloud-based communications. Twin Tech Labs is ensuring the safe and secure operation of the client’s product and confirming the device’s confidentiality, HIPAA, and GDPR compliance.

About RQMIS

Founded in 1996, RQMIS, Inc. is the worldwide leader in therapeutically focused comprehensive regulatory, quality, and clinical consulting to the global medical device, pharmaceutical, nutraceutical and cosmetic industries. The company offers a wide range of products and services designed to execute the most efficient and cost-effective commercialization pathway for our clients worldwide.

Note: The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

For more information and press only:

PR Contact Name: Frank Manning

Phone number: 978-834-5093

Email: frankmanning@rqmis.com

For more information on Twin Tech Labs:

www.rqmis.com www.twintechlabs.io

The Medtech Conference, October 9-11, 2023, Anaheim, CA

The MedTech Conference brings the top executives and innovators from across the world (and the industry) together to explore critical topics, share visions for the future — and build them, together.

RQMIS will be attending as an exhibitor. Our goal is to meet with existing and prospective clients to give them more insight into our unique approach to bringing their products to market.