Start-Up Assistance

"Our greatest weakness lies in giving up. The most certain way to succeed is always to try just one more time" -Thomas Edison

Start-Up Assistance

 

For a new business, trying to figure out the best direction to go can be difficult and, at times, overwhelming. Setting up manufacturing operations, supplier relationships, a quality management system, and preparing regulatory submissions can be a daunting undertaking; especially in the midst of bringing a new product idea to fruition. Our experience in assisting start-up companies with putting the necessary systems and processes in place is unmatched. Additionally, we can prepare all necessary documents for US and international regulatory filings in order to gain entry into those markets.

Start-Up Checklist

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Facility and equipment qualifications

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Work cell layout

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Process validations

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Network qualification and software validation

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Cleaning, packaging and sterilization validation

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Supplier qualification and management

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Quality management system documents

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Employee training

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Design history file creation

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Design and process failure modes and effects analysis (FMEA)

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Clinical trial protocols

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Clinical evaluation reports

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Regulatory strategy

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Technical file and design dossier creation (EU)

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Health Canada Medical Device License (MDL)

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FDA Pre-market application (PMA)

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FDA Pre-market notification (510(k))

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Post-market surveillance plans

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Reimbursement plans

Utilizing internal resources, or through our vast network of subject matter experts, we can help take your product idea from concept through commercialization and beyond. Contact us today to learn how to turn your product idea into a saleable medical device.

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