International Approvals

mdi Consultants  – The Global Regulatory Experts – FDA & 510(k) approvals

mdi Consultants is a management consulting company specializing in the medical industry since 1978. Staffed by former FDA officials and industry experts, mdi Consultants is a leader in the field of FDA regulatory affairs and quality issues, as well as European CE marking and ISO 13485 certification. mdi is the official consulting company for CCUS/CCPIT departments of the Government of China. Services include 510(k) strategies, preparation and submissions, clinical trials, QSR/cGMP compliance and FDA troubleshooting, ISO certification, MDD and IVD assistance and compliance, marketing strategies, strategic planning, project management, and training.


MD 101 Logo Image

MD101 Consulting

MD101 Consulting is a full service company providing medical device manufacturers with quality/regulatory affairs services, clinical affairs services, reimbursement strategy services, health economics services, and business development services. With 12 consultants in France and 12 consultants in key countries (Middle-East, South East Asia and Europe), we highly specialize in software medical devices, health IT, radiology/medical imaging & orthopedic implants.


Beijing JRJ Science and Technology Co., Ltd

A professional consultative and vicegerent company in the field of medical device registration and distribution in China. Beijing JRJ Science and Technology Co. Ltd. (JRJ), set up in 2001, has always been focusing on providing consulting and agency business of medical devices. Since its founding, JRJ has already assisted hundreds of domestic and overseas medical-device manufacturers or agents to register their products in the State Food and Drug Administration (SFDA) of China. JRJ possesses an excellent group of staff who have the background of hospitals, medical authorities and institutes.


ELC Group – ELC Group can help you obtain regulatory clearance, maintain compliance and increase your sales in the world’s largest and fastest growing medical device markets.

As a long established Regulatory Consultancy and Service Provider, we offer an extensive portfolio of business development and regulatory affairs solutions.

Whatever your focus, our unique combination of global resources, expert consulting and deep experience ensure you can maximize your product’s commercial potential.

Our consults have extensive knowledge and experience in all aspects of regulatory affairs across various industry disciplines and a wide range product profiles. And because we stay abreast of current legislation, regulatory requirements, industry initiatives and regulatory interpretations around the world, you don’t have to.


Latini & Associados – Regulatory Services in Latin America

Founded in 1996, the company counts on a specialized technical staff allowing time reduction on process formulation, with gains of efficiency, time, cost and personal designated for this job. Working in association with our clients’ Regulatory Affairs field, we analyze customized solutions, monitor the scenario and manage the inherent regulatory risks of each company activity. We have already served companies from more than 25 countries; and we have obtained the approval of thousands of products. We rely on strategic partnerships in Brazil and abroad, promoting the access of our clients to these global markets. In contemporary globalized world, it is important to count on a strong partner in Regulatory Field in order to overcome the non-tax barriers and, to achieve markets by the increasing of companies‘ businesses.


MethodSense is a life science service firm guiding medical device and biotech companies where Technologies converge with Quality Assurance and Regulatory Affairs.     MethodSense’s core expertise and services include 60601-1 3rd Edition Product Safety Testing Management, Risk Assessment and Risk Remediation, 21 CFR Part 11 and Annex 11 Compliance Strategies, Validation Development and Execution for technologies and manufacturing processes,  Designing Software Controls for Compliance Needs, SDLC Methodology Optimization, Technology Assessments for Procurement or Acquisition.   Our guidance enables clients to operate more effectively during the commercialization process and beyond.  MethodSense delivers breakthroughs.


Cameron Marketing and Communications LogoCameron Marketing and Communications is a full-service New York agency that is devoted to driving sales for our clients.

We have assisted over 100 US and international healthcare companies with product and corporate branding, trade show and online promotions, continuing education programs, Advocate/Opinion Leader development, online and print advertising, and medical writing.

At Cameron Marketing and Communications, when we look at your business, we open our minds to opportunities you may not have considered. Competitive advantages you may not have recognized. Sales messages you may have overlooked. All to deliver return on your marketing investment you may not have imagined possible.

↑ back to top
picture kazurabashi vine bridge

Many bad traps are hidden
in the EU regulatory jungle
We guide you safely

mdi Europa facebook profile mdi Europa linkedin profile

News in Brief


grafik CE mark