Grey Skies can provide everything from initial medical device regulatory strategy determinations, predicate searches and submission guidance, all the way through marketing material reviews, post-marketing guidance and auditing.Regulatory Consulting
Grey Skies can help register your device in any number of countries. We can also help to simplify your global regulatory strategies by highlighting markets that may be easier to register in than others and organizing your registration timelines.Device Registration
We can assist with initial supplier reviews, desk audits and on-site supplier audits around the world. Our consultants have experience with global supplier qualification audits from the United States through Asia.Supplier Qualification
Quality Management Systems are the cornerstones of any medical device company. They can impact almost every aspect of a company’s day-to-day operations. Grey Skies is available to help with everything from streamlining an existing QMS to creating a new QMS for a start-up. We can also perform a company’s internal audits to monitor the health of their quality system; as well as simply provide auditing checklists for your company to use in their internal auditing program.QMS Compliance
In the medical device industry, few things create as much stress as an FDA inspection. It doesn’t have to be that way! Grey Skies can help by providing your organization with the tools to prepare for an FDA inspection, including how to prepare when you have a week’s worth of notice, or only one day… or no notice at all. We are also available to provide inspection training and on-site preparations for those that want the extra hand and guidance.FDA Inspection Readiness
Grey Skies Regulatory Consulting is a boutique medical device regulatory and quality consulting firm. Our regulatory business expertise allows us to be fast and flexible partners in achieving a company’s goals.
What’s in a name? Everything. Grey Skies exists because we believe that working with the FDA and other regulatory agencies shouldn’t be painful. Interacting with regulatory agencies doesn’t have to bring your company the proverbial cloudy day. Let us handle it for you. We can help prepare you and your employees for success in the dynamic medical technology world.
If you’re interested in working with us, or would like to know more, don’t hesitate to contact us. You can either fill out the form or email us directly at info@greyskiesrac.com.
Thank you and we look forward to receiving your enquiry.