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Healthcare product safety: Medical devices Overview

Throughout the medical device lifecycle, establish, document and maintain an ongoing process for: 1. Identifying hazards associated with your medical … See more

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URL: https://learn.marsdd.com/article/heathcare-product-safety-medical-devices/

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 …

Category: Medical Go Health

Healthcare product development: 10 key steps

WEBStep 1: Properly classify your healthcare product (that is, as a drug, a biologic, a medical device or a combination product) so that you know which regulatory …

Category: Medical Go Health

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 …

Category: Medical 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 …

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Step 1: Classify your healthcare product

WEBWording used by different jurisdictions (Canada, US and EU) may vary, but the general principles remain the same. ii Other types of combination products are listed …

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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 …

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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

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 …

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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 …

Category: Medical Go Health

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

Stability: Healthcare products

WEBFor healthcare products that have a shelf life, stability studies play a central role in their development. These stability assessments of the active substance (for …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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Employee benefits and benefits packages: What Ontario …

WEBCompetitive employee benefits commonly include: Health insurance (e.g., coverage for medications, physiotherapy, upgraded hospital care) Employee assistance programs. …

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