Market Consulting and Strategic Regulatory Services

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
- Labeling
IVDR Performance Evaluation Solutions
- Performance Evaluation Plans (PEPs)
- Performance Evaluation Reports (PERs)
- PMS plans
- PMPF plans
- Risk management
- Labeling
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!

Expert guidance on your product’s indications under MDR/IVDR
Insight into the strict MDR stance on product equivalency
Industry-leading professionals staying abreast of the latest changes to the requirements

Strategy and planning for product registration and market access
Experienced team with broad, in-depth knowledge of FDA requirements and procedures
Well-designed regulatory strategy tailored to your product

Strategy and planning for product registration and market access
In-depth knowledge on how to take advantage of clinical evidence collected outside of the EU to obtain market approval
Transitioning from MDD to compliance with MDR
Customized strategies to obtain Conformitè Europëenne (CE) marks
- Assistance with notified body selection and negotiations
- Experts to design and control CE marking studies to meet the demands of notified bodies

Teams established in Europe with ISO 9001- and ISO 13485-certified standard operating procedures that comply with ISO 14155

Experienced team with broad, in-depth knowledge of the Australian Therapeutic Goods Administration (TGA) and private reimbursement requirements and processes, including conformity assessment applications, post-market recall, and adverse event notifications
Expertly designed regulatory strategies for the Australian market tailored to your device using alternative conformity paths such as MDSAP/510(k)
Act as local sponsor of your IVDs & devices while you arrange for an Australian distributor

Developed for turnkey use or through working partnership
Strategic planning and overall regulatory guidance
Interactions with reviewing divisions of the FDA and competent authorities
Interpretation of regulations, standards, and guidelines
Development of bench testing protocols
Development of biocompatibility test strategies
Interactions with test houses
Validation testing guidance and interface (electrical testing, packaging, sterilization, etc.)
Development of animal study designs/protocols
Interface with Good Lab Practices (GLP) animal facilities
Proven track record of successful ethics committee (EC) and institutional review board (IRB) submissions
Experience conducting multicenter trials in Europe, U.K., the Americas, Australia, New Zealand, Asia-Pacific, and the Middle East

U.S. regulatory submissions
- Pre-market notifications — 510(k)
- Pre-market approval applications (PMAs)
- Advisory committee preparations
- 513(g) request for designation
- Investigational device exemptions (IDEs)
- Humanitarian device exemptions (HUDs/HDEs)
- E-copy format for U.S. device applications to be filed with the FDA’s
- Center for Devices and Radiological Health (CDRH)
- E-copy format for U.S. device applications to be filed with the FDA’s Center for Devices and Radiological Health (CDRH)
EU regulatory submissions
- Expertise to lead you through national competent authority submissions
- Technical file, design dossier, and CE mark documents gap assessment and development, including clinical evaluation plan, clinical evaluation report, PMCF plan, PMCF report, and summary of safety and clinical performance
- Notified body selection
- Notified body submissions and interaction
Australian Regulatory submissions
- Regulatory strategy proposals using CE Mark or Medical Device Single Audit Program (MDSAP)/510(k)/PMA approvals for abridged registration process in Australia
- Providing interim sponsorship access to Australian market for international companies until setup of TGA e-business service access for local new clients including preparation of new client ID forms
- Lodgment of manufacturer’s evidence and ongoing certificate updates
- Recommending relevant Global Medical Device Nomenclature (GMDN) codes and verifying Australian classification for your product
- Preparation and submission of medical device and in vitro device (IVD)/diagnostics applications
- Preparation of Level 1 and Level 2 application audit submissions to the TGA
- Preparation and collation of full conformity assessment applications and device dossiers if full conformity assessment is required
- Preparation of manufacturer’s declaration of conformity
- Australian Register of Therapeutic Goods (ARTG) Device change requests
- Preparation and submission of annual reports for Class IIb and Class III medical devices
- Assisting with supply of unapproved therapeutic goods via the TGA’s Special Access Scheme and/or Authorized Prescriber Program
- E-business notification and coordination of device recall actions and overall management of communications with the TGA’s recalls section
- Electronic submission of incident reports for adverse events
- Coordination and preparation of formal responses to the TGA’s post-market surveillance section regarding technical enquiries on included devices’ technical file and/or compliance to Australian essential principles
- Sponsor and Web Assisted Notification of Devices (WAND) listings to Medsafe in New Zealand
- Support client acquisition regulatory (i.e., due diligence and ARTG) transfers for local sponsors only
International design dossiers
- Health Canada applications
- Local teams with in-depth knowledge of your target country’s national requirements, guidelines, and timelines
- Latin America applications
- Expertise to lead you through national competent authority submissions

Preemptive guidance on the PMCF format best suited to your post-market requirements
Planning and executing any extensions of your product’s indications
Specialized support in targeted clinical investigations, case series reports, PMCF surveys, and post-market literature review

Summaries of safety and clinical performance
PMCF plans and reports
Warning letter mitigation and resolution
Medical device reporting (U.S., EU, Canada, Australia) and complaint handling
Safety and post-market surveillance (PMS) reporting
Comprehensive, well-designed PMCF studies to optimize your product’s potential
Expert design, conduct, analysis, and reporting for PMCF studies
Results that strengthen your marketing and sales efforts through increased scientific credibility and product exposure

Guidance for the entire regulatory process
Experience working closely with EU notified bodies
Assistance with all regulatory discussions
Vigilance for evolving regulatory requirements by country and region

Pre-market and post-market assistance
Tracking/trending product complaints
Complaint reporting to regulatory bodies (U.S., EU, Canada, New Zealand, and Australia)
Metrics for management reviews

Assistance executing the prescribed field action strategy, including product recall
Facilitation of necessary initial, follow-up, and closure reports to regulatory bodies (U.S., EU, Canada, New Zealand, and Australia)
Timely and compliant reporting
Assistance in developing appropriate Corrective and Preventative Actions (CAPAs) required by your quality system