New Product Approval for Medical Devices
According to a 2017 medical device industry survey, “Regulatory changes continue to represent the biggest business challenge to most survey respondents.” With the explosion of innovations in the medical devices industry has come more stringent FDA regulations for companies to follow. It can quickly become overwhelming for businesses of any size to keep up with demands as they seek the approval of a new product, but you don’t have to navigate these new product approval challenges alone.
Let Regulatory Compliance Associates® Inc.’s team of experts guide you through the constantly changing domestic and international regulations to successfully register your medical devices. From pre-submission strategies to international submission support, our expert team has the unique insight necessary to help you take your products to the next stage of product development. We offer many new product approval support services that will help you stay within regulatory compliance throughout each stage of the regulatory submission process, including:
Global Regulatory Strategies
When you’re seeking new product approval internationally, you need the guidance of experts that have worked with regulatory authorities around the world. RCA will work with you to create successful global regulation strategies through services such as:
- International Regulatory Strategies
- Product Classifications
- FDA 513(g) Request
- International Registration
Before you even submit your product for approval to the top regulatory authorities, you’ll need to have a strategy in place to determine the most appropriate pathway to obtain clearance. You’ll be far more prepared to talk to the FDA and other regulatory bodies as we support you with services including:
- Preparing and Conducting Pre-Submission Meeting with FDA
- Regulatory Strategy
- Evaluation of ISO 13485 and FDA Compliance
Domestic and International Submissions Services
Whether you’re only submitting your product for approval in your own country or are looking to sell in markets around the world, RCA will create a strategy unique to your goals. We help you navigate the 510(k) approval process for medical devices and guide you as you work with regulatory authorities from around the world.
Our domestic and international services include:
- Technical Writing: 510(k) submissions, PMA submissions, De Novo, Technical Files, Clinical Reviews, Explanation Letters, etc.
- Submission Preparation and Filing with Regulatory Authorities
- Pre-Market Notification (510(k))
- Pre-Market Approval (PMA)
- Innovative Regulator Pathways (i.e., De Novo)
- Humanitarian Use Device (HUD) and Device Exemption (HDE)
- European Union Technical Files and Class III Design Dossiers
- Facilitation and interaction with regulatory authorities
Submitting your product for clearance isn’t the last step in the product approval process — you’ll also have to register and list your device, and you’ll need to identify a U.S. Agent if you’re a foreign company importing your product into the U.S.
RCA is here to guide you after your device is submitted and can even act as your U.S. Agent to assist in future FDA communications. Our services include:
- FDA Establishment Registration and Device Listing
- U.S. Agent Services
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.