Learn.marsdd.com

Step 5: Establish your healthcare product development plan

WebBefore placing a drug, biologic or medical device on the market, a multi-phase procedure must be followed. A typical drug or biologics product development …

Actived: 1 days ago

URL: https://learn.marsdd.com/article/step-5-establish-your-healthcare-product-development-plan/

Medical device regulations, classification and submissions

WebDue to the wide variety of medical devices, these products are regulated on a risk-based classification system. In Canada and the EU, devices are grouped into four different …

Category: Medical Go Health

Healthcare product development: Study protocols, …

WebIn a regulated environment, regardless of the type of healthcare product development pursued (for example, of a drug, biologic or medical device), studies need …

Category: Medical Go Health

Medical device submissions: Placing a medical device on …

WebThe procedures required to legally place a medical device on the market vary in Canada, the US and the EU. Different regulatory bodies are involved, requiring different types of …

Category: Medical Go Health

Healthcare product development: 10 key steps

WebHealthcare product development (that is, the development of a drug, biologic or medical device) is a long and complex process. It is critical to know the general …

Category: Medical Go Health

Step 3: Determine your healthcare market

WebTo support your product development program, identify and review regulatory requirements from international groups as well as the country-specific requirements related to your …

Category: Health Go Health

Validation & healthcare products

WebValidation and healthcare products. When manufacturing a healthcare product, be it a drug, a biologic, or a medical device, validation activities (including that of …

Category: Medical Go Health

Step 1: Classify your healthcare product

WebReserve a spot. Step 1: Classify your healthcare product. Healthcare product development is complex. It is critical to know the general product development lifecycle …

Category: Health Go Health

A brief guide: Healthcare market research tactics

WebWhile there are many general market research resources available for the U.S. and Canada, these public resources can help you to understand the potential market for your therapy …

Category: Health Go Health

Product development: Positioning new healthcare products in the

WebNew healthcare products often begin with a technological innovation or biological insight that aims to address a need or improve current technology in the …

Category: Health Go Health

Importance of quality: Raw materials of healthcare products

WebManaging your raw materials as part of your quality system will help to ensure that your finished healthcare product meets its quality attributes. It is wise to …

Category: Health Go Health

Healthcare regulatory submissions: A primer

WebA regulatory submission for a healthcare product includes any documentation or information submitted to a regulatory agency for review, for notification or in response to a request …

Category: Health Go Health

How Startups Can Connect With Payers and Other Key Players

WebThese four US-based stakeholders explain how they connect with entrepreneurs and their various types of “front doors.”. Speakers: Zain Ismail, Principal Transformation …

Category: Health Go Health

Sterilization: Healthcare products

WebSterilization: Healthcare products. According to the US Centers for Disease Control and Prevention, sterilization means “the use of physical or chemical procedure to destroy all …

Category: Health Go Health

Step 9: Collate your regulatory submission

WebThis article outlines step 9 of the 10 steps to develop a healthcare product. In the development of a healthcare product, the regulatory submission is intended to “tell a …

Category: Health Go Health

Pre-submission regulatory meetings: Preparation

WebWhen developing a healthcare product, effective communication with your regulatory agency is critical. This holds especially true at key milestones, which may …

Category: Health Go Health

Step 10: Ensure post-marketing compliance

WebHowever, such registration means that the site is included in the FDA database and that your establishment is subject to FDA inspection. 5. Read the previous …

Category: Health Go Health

Threat of Substitutes, Industry Competition Porter’s Five Forces

WebThreat of substitutes (from Porter’s five forces analysis) occurs when companies within one industry are forced to compete with industries producing substitute products or services.. …

Category: Health Go Health