In today’s ever-evolving regulatory environment, achieving and maintaining market access for a new medical technology is a key strategic decision for manufacturers. Innovative medical products require innovative strategies to obtain regulatory clearance and maintain post-approval compliance in a complex global market. Our team is actively engaged with research pipelines and industry trends across a host of therapeutic specializations, making it possible for us to stay ahead of upcoming regulatory changes and anticipate your needs going forward.
Avania’s regional experts will partner with you to meet your specific business objectives. Whether you’re looking to enter a new market, stay compliant post- approval, evaluate transition plans from Medical Device Directive (MDD) to Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), or expand on indications, we have efficient and effective strategies to support your product’s entire life cycle.
What’s Your Strategy?
Developing a regulatory program starts with questions — a lot of questions. The answers to these questions inform your regulatory strategy, which is your guiding light to the finish lines of submission and approval:
- What is the most appropriate path to market? Is there more than one to choose from for the product?
- What is the product classification?
- How will the product be regulated?
- What are the preclinical test requirements?
- What standards will the product be evaluated against?
- What are the quality system requirements?
- Will this product need a clinical study?
- How can existing data be utilized to accelerate clinical development and achieve market access in new target regions?
- What are the post-market considerations?
Avania shapes these answers into a sound strategy using comprehensive regulatory assessments shaped by your technology and possible product indications. We advise clients on all aspects of regulation in the U.S., Canada, EU, Australia, New Zealand, and Asia-Pacific.
Our Regulatory Services
From start to finish, your MedTech product has a long journey ahead. Each stage of development brings its own set of obstacles, and Avania’s guidance will help you overcome each of them in turn throughout the entire life cycle of the product:
- Global Regulatory Strategies (U.S., EU, U.K., Australia, New Zealand, and Asia-Pacific)
- Global Market Access Consulting
- New Product Development
- Regulatory Submissions
- EU MDR Implementation
- EU IVDR Implementation
- Food and Drug Administration (FDA) Strategy and Submissions
- MDR Clinical Evaluation Solutions
- Clinical Evaluation Plans (CEPs)Clinical Evaluation Reports (CERs)Post-Market Surveillance (PMS) plans/reportsPost-Market Clinical Follow-up (PMCF) plans/reportsPMCF user feedback surveysRisk management
- IVDR Performance Evaluation Solutions
- Performance Evaluation Plans (PEPs)
- Performance Evaluation Reports (PERs)
- PMS plans
- PMPF plans
- Risk management
- Market expansion and international registration
- Management of product complaints
- Corrective action and product recalls
Avania can offer your product development a boost from the very beginning, utilizing pre-market data and proven preparation to speed up every step of the process.
Uncover every component of Avania’s industry-leading assistance — from start to finish!