FDA and Canada MDSAP Audit Certification Consulting

The Medical Device Single Audit Program (MDSAP) is a cooperative program between the US FDA, Canada, Brazil, Japan, and Australia. MDSAP goal is to lessen the repetitive audit burden upon medical device companies. Health Canada lead the way and required MDSAP certification in January 2019.

An MDSAP scope often extends well beyond your quality management system procedure and standard checklist-based audits. An MDSAP can include two auditors plus observers from FDA, Health Canada, and your Notified Body. This type of audit takes effort, but it can save time since one successful audit satisfies all five regulatory bodies.

Medical Device 510(k) Submission Consulting for FDA Clearance

The US FDA annually ‘approves’ over 2,000 traditional medical device FDA 510(k) submissions. A significant number of those submissions are rejected or abandoned by the manufacturer because the required testing was not conducted, guidance not followed, or other requirements not followed.

Axeon can help you navigate the FDA approval process. We understand the FDA process and the pitfalls to avoid. This results in a faster preparation and submittal process with a less chance of an initial “refuse to accept” rejection or an Additional Information (AI) request from the FDA reviewer.

Clinical Evaluation Report (CER) Development & Transition Support

Axeon helps device manufactures assess the impact of MEDDEV 2.7/1 Rev 4 and the new EU MDR on their products and then update existing CERS or develop new CERs accordingly.

The new European Union Medical Device Regulation requires every new medical device sold in EU, regardless of its classification, must have an up-to-date Clinical Evaluation Report (CER).

EU MDR published in May 5, 2017, and has a 3-year transition period, the CER content changed additional safety and clinical evidence may be required for certain device types and classes of devices. This applies to devices already on the market as well as new products.

FDA Premarket Approval (PMA) Application Medical Devices

Expert guidance for each phase of your FDA PMA approval effort including pre-submission with the FDA, Clinical trail management, quality system compliance and final FDA registration.

Premarket approval (PMA) is for devices that support or sustain human life, are of substantial importance in preventing human health impairment, or present a potential risk of illness or injury. This review is both scientific and regulatory by the FDA to evaluate the safety and effectiveness of Class Iii medical devices. Due to the risk of these devices, the FDA decided that general and special control alone are insufficient to ensure their safety and effectiveness.

PMA is the most stringent type of device marketing application required by the FDA. FDA approval must be attained before marketing the device.

Quality System Implementation: FDA GMP, ISO 13485

Axeon offers a structured method for implementing a quality system that is compliant with FDA’s Quality System Regulation (21 CFR 8290) and/or ISO 13485.

Axeon offer a balanced approach for QMS implementation that combines planning, training and follow-up consultation to ensure all activities relate to a successful quality system that efficiently implemented and sustainable.

Axeon starts with understanding your current level of compliance and showing where opportunities for improvement exist. We then develop an Action Plan for moving toward certification / compliance. Company management is given the information needed to make informed assessment of time and resources to attain certification / compliance.

Axeon works hand in hand with the company team to implement the Action Plan.

FDA QSR, MDSAP & ISO 13485 Audit Support

Axeon helps organizations achieve certification and compliance to ISO 13485, FDA’s QSR, European Medical Device Directives, and Medical Device Single Audit Program (MDSAP).

FDA 483 & Warning letter Response

Has your company received an FDA Form 483, a warning letter, or does it need immediate help during an FDA inspection? Call us at 1-877-782-3405

An Axeon consultant will help you formulate and effective response and remediation plan. This plan addresses cited deficiencies, determine root causes, and identify any systemic issue to prevent recurrence.