Medical device companies in the USA typically have to comply with various diverse and rigorous standards mandated by a host of different regulatory bodies, before they can launch their product in the market.

Perhaps the most significant and stringent of these are FDA submissions, and medical device organizations need extensive documentation in order to obtain the relevant accreditation required to distribute the product in the market. Here’s where experienced regulatory writers can prove to be a major asset in terms of helping the companies cross the ever-evolving regulatory landscape.

Experienced regulatory writers can help companies prepare and curate a wide variety of documents, including premarket notification submissions (510K), FDA submission documents, premarket approval applications (PMA) etc. These documents are essential in order to attest that the product meets the laws and regulations mandated by the concerned authorities, as well as to prove the safety and efficacy of the device itself.

Whilst companies do opt to keep FDA submission consultants and regulatory writers in-house, the relatively low frequency of need as well as the high onboarding cost make a case for the merits of outsourcing. With the the growing development of remote/hybrid work modes, companies can stand to gain a lot of benefits from on-demand consulting,

• Access to the top regulatory and FDA submission consultants across the globe, giving them an opportunity to scout and find the best fit for your business needs.
• Flexible consulting durations, which ensures that the freelance FDA submission consultant you hire is available at your convenience throughout the duration of the submission and approval process.
• Cost-effective consulting, as freelance experts are typically cheaper than full time hires, whilst possessing the same wealth of experience accumulated through years of high profile consulting.

Freelance FDA submission consultants and regulatory writers on Kolabtree, for instance, are available to be consulted for both short and long term projects, and can be contacted directly within the platform. 

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