{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F06dfdd0e-954f-4b45-9354-2024afd54a1c","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Questions to Ask Before Hiring Your QA/RA Consultant","description":"Do you work with regulatory consultants to implement a quality system or 510(k), or perform other tasks? Are you asking your consultants the right questions?\n\nOn today\u2019s episode, Jon Speer talks to Allison Komiyama of AcKnowledge Regulatory Strategies about tips, pointers, and key questions to consider before hiring consultants to help you with quality and regulatory work.\nMany companies ask the wrong questions. Allison offers them the right questions to ask multiple consultants to find the best fit.\n\n\n\nSOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:\n\u25cf Example of what not to ask: Have you done a submission for this exact type of device? Instead, ask: How many submissions have you worked on recently?\n\n\u25cf Ask questions about familiarity and price - pay more to get the job done correctly and through FDA faster.\n\n\u25cf You need to like the person you\u2019re dealing with; be comfortable with your consultant because they will be your coach and extension of your team.\n\n\u25cf Collaborate with other consultants to fill knowledge gap, don\u2019t view them necessarily as competition.\n\n\u25cf Familiarity with current FDA and other regulatory best practices and expectations tends to be more important than being familiar with a specific type of device.\n\n\u25cf Avoid consulting experiences gone bad. Lots of experience does not equal the right type of experience you need for your product. Review their references.\n\n\u25cf For quality systems, don\u2019t focus on how much it costs. Instead, does the consultant build a sustainable system that scales, grows, and meets needs?\n\n\u25cf A quality system and design controls do not need to be painful; should be designed to avoid gaps and prevent mistakes.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/981f1415-4299-49d5-a0a2-15203637a72e/91b363fd-02ae-4e4b-9f77-f5c8e494bffc.jpg"}