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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 …

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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: 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 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 …

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Step 2: Identify your healthcare claim and product label

WEBRead the next step in the 10 steps to develop a healthcare product: Step 3: Determine your healthcare market. Read the previous step: Step 1: Classify your …

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Healthcare product development: Study protocols, reports

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 the market

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

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

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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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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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 …

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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 to destroy all …

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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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Stability: Healthcare products

WEBReserve a spot. Stability: Healthcare products. For healthcare products that have a shelf life, stability studies play a central role in their development. These stability …

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Drug development: Drug submissions and the harmonized process

WEBIn the process of drug development (bringing a drug or biologic to market), obtaining a marketing authorization is the final step. To reach this stage, the data …

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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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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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Drug submissions: Procedures to reach regulatory approval

WEBEach jurisdiction has its own procedures to review drug submissions filed to their regulatory agency. These procedures can vary substantially with respect to how the drug …

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