Regulatory Affairs

Did you know there are different regulatory pathways (and corresponding deliverables) depending on where you want to market your regulated product? It’s true, and country- specific requirements can be different and even conflicting, making things more confusing, time-consuming, and expensive. A clear, concise, and detailed regulatory strategy compiled by experts with real-life experience and knowledge can save time, money, and the frustration of delays and problems with regulatory agencies during the review.

Global Regulatory Strategies

MBCA provides comprehensive regulatory consulting services for small companies and startups attempting to get their medical device through the regulatory process.

We have the real-world experience and expertise to determine what class your device ﬁts into, what type of regulatory submissions are required, what predicate devices are most appropriate, what clinical data is needed to get you to market, and how much time and money it will cost you before you can start making a proﬁt. No matter what phase you’re in, MBCA can provide direction and hands-on support to help you.

Country-Specific Commercialization Plans

Country-Specific Regulatory & Commercialization Plans Did you know that your regulatory & commercialization pathway is dependent upon where you want to market your product? Every country has its own requirements and often different classifications for the same product. We will help you navigate the requirements for each country and develop plans that fit into your overall commercialization goals. We have regulatory experience in Canada, Australia, New Zealand, China, Singapore, Malaysia, India, Switzerland, UK, Germany, Spain, Italy, Benelux, Japan, Thailand, Republic of Georgia, Brazil, Ireland, and France.

Country-Specific Product Classifications

US FDA Meetings: Pre-sub meetings, 513(g) filings Do you have questions about the classification of your device or what special controls will apply? Do you have a novel technology but don’t know how to initiate a discussion with the FDA? We have seasoned pros who liaison on your behalf with the FDA. We will explain every step of the process, help you set up the meetings, file the necessary paperwork, submit the required documentation, and represent you in the meetings.

Country-Specific Regulatory Submissions

US Regulatory Submissions: 510(k), DeNovo, PMA No regulatory submission experience? No problem. We will do all the technical writing and thoroughly review the completed submission to make sure everything is in order before we send it to the FDA. Once submitted, we will defend your submission during the review process and assist in securing your market clearance or approval for your device.

Global Reg Agency Communications & Meetings

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Clinical Evaluation Reports

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Interim Regulatory Professionals

Do you need temporary regulatory affairs personnel to help with an uptick in workload? Do you need interim regulatory affairs personnel while you look for full-time employees? We have professionals that can hit the ground running and support your organization for as long as you need us.

Regulatory Due Dilligence

Regulatory Due Diligence Need an independent expert to perform Due Diligence audits? Our professionals can help you assess the risks and provide detailed reports and recommendations.

Need Immediate Assistance? Have you received a regulatory notice or a major finding during your ISO audit? We can help you respond and quickly formulate corrective actions to prevent further disruption to your business. Get Assistance

Upcoming Inspection or Audit? Leverage our decades of experience by letting us help you confidently prepare for your inspection or audit. Get Started

Taking your first product to market?

We can help you navigate the maze of regulations and avoid common mistakes. Need a Regulatory Strategy? We can help. Need your first Quality Management System? Ask us about IntelaSolve eQMS. Contact Us

Contact our experts How can we help?

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Need Immediate Assistance?

Have you received a regulatory notice or a major finding during your ISO audit? We can help you respond and quickly formulate corrective actions to prevent further disruption to your business.

Get assistance ›

Upcoming Inspection or Audit?

Leverage our decades of experience by letting us help you confidently prepare for your inspection or audit.

Get started ›

Taking your first product to market?

We can help you navigate the maze of regulations and avoid common mistakes. Need a Regulatory Strategy? We can help. Need your first Quality Management System? Ask us about IntelaSolve eQMS.

How can we help?

Tell us what you are working on and we will point you at the fastest route to compliance.

Schedule a free consultation