: info@mdiconsultants.com
: 516-482-9001
mdi Consultants Inc., with 45 years of experience in FDA regulatory compliance to the medical device, pharmaceutical, and food industries, is a leading provider of regulatory compliance consulting, FDA consulting for quality assurance, as well as International medical device compliance, and clinical services to the healthcare industry.
mdi Consultants’ services are focused on assisting medical device companies, pharmaceutical manufactures, and food industry companies across the globe to help them achieve regulatory and standards compliance.
mdi Consultants takes pride on keeping up-to-date on all aspects of the international healthcare industry; and, in some cases, ahead of the industry. Our News and Information section, our Insights Reports, our FDA Updates, and our newsletter are no different.
mdi Consultants provide up to the minute E.U. and FDA consulting services, tailored to the medical device industy, IVDD, pharmaceutical manufacturers and companies, and the food, nutrition and nutritional supplement industries.
September 6, 2024
Recently, I came across an FDA regulatory situation you do not see too often. On the same day, FDA sent two teams of field investigators into two geographically different sites of the same company to conduct a QSR/cGMP (21CFR820) inspection. An FDA inspection is always a stressful experience but having two simultaneous inspections certainly raises the pressure on the company even more.
Why would the FDA decide to use this simultaneous inspection approach? This reminded us of another similar situation that mdi was involved with once before. This was many years ago but then FDA methods do not change much.
In that case, our client was a company that had three separate divisions. At different times, FDA had conducted inspections of each of these divisions. Each time, FDA inspection resulted in the Form-483 (List of Inspectional Observations) that showed that the company had systemic problems in complying with the QSR regulations.
While the company attempted to respond to the 483s and proposed certain corrective actions, FDA felt these were not sufficient to properly address the QSR noncompliance. FDA was willing to take additional regulatory actions and issued a warning letter to the company reiterating their initial 483 observations as well as FDA’s dissatisfaction with the proposed corrections.
All foreign establishments of medical devices, human and animal drugs, and biologicals who manufacturer any of these products must have a designated agent in the USA:
medical device manufacturers, human and animal drug manufacturers, biological manufacturers.
Our FDA compliance service line will get your products to market quickly and to maintain your FDA compliance status. mdi has helped hundreds of companies to achieve and maintain their FDA compliance.
mdi Consultants provides Health Canada Regulatory consulting services as it has extensive experience with various regulatory submissions to Health Canada and can assist with bringing your products to Canadian market: Medical Device Classification, Medical Device Licensing for class II, III and IV, and more.
mdi Consultants can guide you to determine what is the best way to achieve a CE Mark and assist you through the entire process of securing it. We have helped over 100 companies successfully achieve the CE Mark. Our customer testimonials will provide you a glimpse of the experience of working with mdi on CE Marking.
mdi Consultants now offers software penetration testing to demonstrate full conformance with cybersecurity requirements under ISO 27001 and FD&C Act section 524B “Ensuring Cybersecurity of Medical Devices” for businesses engaged in software usage for their medical devices and other related regulatory products produced under ISO and FDA standards.
Medical devices commonly use cloud-based software, Bluetooth connectivity, and wireless remote controls as methods of operating the equipment and transferring data. These connections expose the devices to the possibility of outside interference, or hacking, which can result in device malfunction or control of the device passing to an unauthorized outside user.
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Posted on September 8, 2024Over 200 years of cumulative industry experience on staff
Helped over 500 companies achieve FDA compliance and/ or ISO certification
Successfully prepared and submitted over a 1800 510(k) applications
Earned a 100% success rate in first time ISO certification
Successfully assisted obtaining CE mark for over 1000 products
Successfully assisted obtaining CE mark for over 1000 products
To Whom It May Concern:
How does a small, growing business navigate the FDA medical device registration process?
Short answer – they really don’t, even after hours & hours of research!
mdi Consultants are not only super professional, expedient and amazing at what they do but they are also caring, real humans who made the process of registering our company and medical device with the FDA effortless for us.
Finding mdi Consultants is a great example of why we always look for people to join our Team that can do something we do even better – the mdi team is awesome at what they do and they understand (and patiently explain) the FDA system and processes.
Thank you, mdi Consultants 🙂
Holli Markwald,
CEO,
Prairie Wear Ltd.
Dear Alan,
We want to express our appreciation for MDI’s guidance and assistance in helping us achieve our MDSAP (Medical Device Single Audit Program) certification. At this time, the MDSAP process is very new to both the companies wishing to obtain certification and the auditors. Success is only possible with in-depth understanding of all MDSAP requirements and their complete implementation.
The MDI Consultant team worked closely with our staff throughout the entire process providing stable and consistent support. Though there were several unexpected obstacles along the way, you continued to work and support the FEI staff to achieve its goal.
MDI’s professional and timely commitment to helping us achieve the MDSAP certification goal is exemplary. We hope to continue to work with MDI to support the compliant operations of our quality system as well as for other future projects.
Elliot Goldbesrg,
President,
Fabrication Enterprises Inc.
Dear Alan,
We want to thank mdi for your assistance with the most recent FDA inspection of our facilities in Taiwan.
Your guidance and composed demeanor throughout the inspection demonstrated your extensive experience and expertise in navigating FDA inspections and working with FDA investigators.
The inspection results were outstanding, and we cannot imagine going through future FDA inspections without the support of mdi. We strongly recommend mdi to any organization seeking assistance with the FDA.
Once again, we express our gratitude for your exceptional expertise and experience in ensuring the success of the inspection.
Best regards,
Jonathan Cheng
President
Merits Health Products Co., Ltd.
Taichung City, Taiwan
mdi Consultants
