Mdiconsultants.com

FDA Medical Device Compliance IPharmaceutical …

Webmdi 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 …

Actived: 7 days ago

URL: https://mdiconsultants.com/

About mdi Consultants, Inc. Consultants to the medical device

WebFor the Medical Device, Pharmaceutical and Food industries, MDI Consultants stands as a beacon of expertise, offering tailored solutions to meet and …

Category: Food, Medical Go Health

U.S. Agent to the Food and Drug Administration (FDA)

WebA U.S. Agent to The Food and Drug Administration (FDA) must be a resident of the United States, or have a physical place of business in the United States. A U.S. …

Category: Food Go Health

FDA User Fees for FY 2024 – Medical devices

WebThe new 510 (k) for small business is being increased around 10% to $5440. DeNovo fees also will increase about 10% to $36,267. Below is the schedule for the 2024 FDA fees for …

Category: Health Go Health

Services to the medical device, pharmaceutical and food industries

Webmdi Consultants offers a full range of services to the healthcare industry. Our services are focused on assisting medical device, pharmaceutical and food companies …

Category: Food, Medical Go Health

Medical Device Consultants, Healthcare Consulting/mdiConsultants

Webmdi Consultants, Inc. has been serving the medical device industry for four decades; and, as FDA Medical Device Consultants, we have extensive experience in …

Category: Medical Go Health

MDSAP The Medical Device Single Audit Program from …

WebThe Medical Device Single Audit Program (MDSAP) is a new plan in the final year of a three-year pilot program. This plan will likely become permanent beginning in 2017. The …

Category: Medical Go Health

NDC/NHRIC Labeler codes for Medical Devices – FDA’s stand

WebThe application of FDA labeler codes and NDCs/NHRICs (National Health Related Item Codes) to medical devices was an interim solution for device identification. As FDA …

Category: Medical Go Health

Health Canada to Use US FDA’s Electronic Submission Gateway …

WebDeliverable Outcome: Implementation of a Common Electronic Submission Gateway, using the current US gateway, that allows industry clients the ability to submit large size …

Category: Health Go Health

Draft guidance announcement! Medical Device Accessories

WebAccessories to medical devices, what are they and how does FDA regulate them? FDA released a draft guidance document to address just this question.

Category: Medical Go Health

Food Industry Consultants FDA Consultants

WebFood Industry Services. mdi Consultants, Inc. a Food Industry Consultant, has been offering food industry services for over a quarter century. We have extensive …

Category: Food Go Health

FDA update: FDA Issues Final Orders to Reclassify

WebWe were always curious about how the FDA classified blood lancet devices as 510(k) exempt. Well, now the FDA has finally decided that blood lancets do require a …

Category: Health Go Health

Make your Old Medical Device “New” Again

WebFDA requests your comments!! With concern about the quality, safety and continued effectiveness of medical devices which have been subjected to continued servicing

Category: Medical Go Health

Guidance on Formal Meetings and User Fee Applications

WebCOVID-19 – Guidance on Formal Meetings and User Fee Applications. Due to the COVID-19 public health emergency, the FDA has released a new guidance document titled …

Category: Health Go Health

Medical Device Reimbursement Services by mdi Constultants

WebAbout mdi Consultants. mdi Consultants, Inc. is a leader in providing consulting services to the healthcare industry worldwide. We have extensive expertise in …

Category: Health Go Health

Health Canada Regulatory Consulting services

WebMarketing Medical Devices in Canada, the manufacturers, private labelers, importers, and distributors of Medical Devices are required to meet all requirements of …

Category: Medical Go Health

How to Construct a Value-Driven Dossier to Present to Payers for

Web16Oct. How to Construct a Value-Driven Dossier to Present to Payers for Coverage. Good clinical studies are the most important piece of data to have to present in a dossier …

Category: Health Go Health

ISO Compliance and ISO Quality Standards Medical Devices

Webmdi Consultants has assisted over 150 companies achieve compliance across a wide array of ISO standards: ISO 9001:1994. ISO 9001:2000. ISO 13485 (EN …

Category: Health Go Health

FDA Update: Policy for Testing of Alcohol (Etha4nol) and Isopropyl

WebSince the beginning of the pandemic, the FDA has been in observation of reports of serious adverse events related to ingestion of alcohol-based hand sanitizers. The FDA has also …

Category: Health Go Health

Reimbursement Stakeholders

WebIt is extremely important that those who work in a medical device company know the various players they must deal with to achieve success. A provider is a person or institution who …

Category: Medical Go Health

Design Considerations and Premarket Submission …

WebFDA wants your comments!! Your chance to be heard!!!!! FDA announced an opportunity for public comment on the guidance document for Design Considerations and premarket …

Category: Health Go Health