Accorto Regulatory Solutions U.S. 510(k) technical dossier submission |

Accorto Regulatory Solutions

U.S. 510(k) Premarket Notification

A 510(k), formally known as a Premarket Notification, is a technical dossier submission that is required by the Food and Drug Administration (FDA) for qualifying medium-risk medical devices and in vitro diagnostic devices (IVD) to be legally marketed and distributed in the United States. These submissions must demonstrate the device meets product-specific safety and efficacy standards set by US regulatory agencies and prove the device is substantially equivalent to a predicate device (a device that has already been cleared by the agency for commercialization in the US) to be granted market authorization. Accorto offers full turnkey solutions for 510(k) medical device submissions. Contact us today to discuss how our team can achieve and maintain US market authorization for your medical devices.

510(k) Preparation and Submission Services

At Accorto, we know gaining market authorization in the US for your medical device can be one of the largest roadblocks your company will face on your journey to achieving your long-term business goals. Preparing a 510(k) can be challenging, and mistakes can result in severe setbacks to both your project timeline and budget.

Our team of regulatory experts specialize in the management of medical device and IVD regulatory submissions, working collaboratively with each of our clients to develop bespoke submission strategies unique to their specific device, intended device use, and their long-term business goals. Whether you are looking for a full turnkey management solution or guidance on how to manage your own submission, our team can help you achieve market authorization for your medical devices quickly and efficiently.

510(k) Post-Market Surveillance Management

Post market surveillance is the practice of monitoring the safety and efficacy of a medical device after it has been released to the market in the US and is a requirement to maintain market authorization with the FDA. Manufacturers are required to collect and report any data gathered on adverse effects from the device post-market. Once an adverse effect has been reported, the manufacturer is also required to investigate each report and promptly inform the FDA the results of their investigation and if the incident was directly related to the device in question. Failure to properly monitor, investigate, or report post-market surveillance data may result in the termination of the device’s market authorization.

Accorto offers full turnkey post-market surveillance management solutions as a part of our suite of 510(k) service offerings. From initial surveillance plan development and implementation, to collection of incident reports and device usage feedback from customers and patients, to periodic report development and submission and annual reporting, Accorto can manage your full post-market surveillance process start to finish and every step in-between.

COVID-19 EUA Transition Services

FDA has begun revising their guidance and reducing the EUA scope for COVID-19 related devices. Companies currently marketing COVID-19 related medical devices under the EUA pathway will need to ensure they comply with all regulatory requirements for 510(k) premarket notification submissions if they intend on continuing commercialization following the conclusion of their EUA. At Accorto, we will develop a post-EUA submission strategy to achieve and maintain long-term market authorization for your in vitro diagnostic devices, personal protective equipment, and respiratory assistance devices, far beyond the COVID-19 pandemic.

Contact Us to Speak With an Expert Today

About Accorto Regulatory Solutions

What we do

At Accorto Regulatory Solutions, we specialize in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market. Our organization has perfected our processes to help companies develop bespoke, cost-effective concepts in a number of different FDA regulated areas including:
  • Regulatory dossier submission strategies for new tobacco products, medical devices, drugs and other regulated consumer products including but not limited to premarket dossier preparation, publishing, and electronic submission.
  • Design, planning and commissioning of compliant manufacturing facilities, cGMP SOP packages and Quality Control Systems implementation. Additional services include development, publishing and electronic submission of FDA compliant production Masterfile dossiers as well as comprehensive compliant site management services.
  • As an authorized regulatory agent, we can provide regulatory support by managing responses to FDA inquiries, deficiency letters, formal meetings with Agency, on-site audit support and annual product surveillance and post market reporting requirements.

How we do it

Our key to success is speed and flexibility, while never compromising quality or our customers’ confidential information. Our promise is to put our customers’ needs at the heart of everything we do and deliver you results without excuses that are right the first time, every time. This is managed by our highly experienced leadership and technical teams, made up of industry experts with backgrounds in medical devices, diagnostics, pharmaceuticals, cosmetics, and tobacco.

Why choose us?

At Accorto Regulatory Solutions we offer the best of both worlds in the regulatory industry: the speed, flexibility, and personalization of a small agency with the resources and expertise of a large company. Without the bureaucracy and red tape you would get with a large agency, our team is able to provide custom tailored solutions to our clients’ regulatory challenges big and small, saving them time and money on every project. With a network of some of the nation’s leading CRO’s and industry experts on speed dial, we will always have the right people at the right time to solve your regulatory challenges quickly and effectively.

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