REGULATORY MANAGEMENT
Successful regulatory submission is a prerequisite for gaining market approval. Approved regulatory submissions for medical devices require explicit adherence to specific content and format requirements since every regulatory agency has unique requirements, and those complex requirements often change. Regulatory communications with the appropriate authority staff members may even be necessary for timely approval to guarantee successful regulatory submissions.
The MedXfile team are specialists who understand the evolving regulatory affairs for medical devices. We are experts at creating and presenting submissions for approval by worldwide regulatory agencies. Each of our regulatory compliance consultant experts has decades of cumulative experience and is collectively responsible for hundreds of successful submissions.
Our staff’s comprehensive knowledge of the regulatory submissions process appoints each regulatory affairs consultant as a leader for your company’s questions and needs.
From a single strategist to a team of experts, the MedXfile professionals will work collaboratively with your team to fill your company’s gaps. We have a robust staff that has extensive industry experience with varied skillsets so our staff augmentation services can devote a specialist to each of your company’s unique needs.
Our comprehensive services manage all the tasks and labor associated with medical device regulatory submissions, quality systems regulations, and fulfillment demands. Our team assists with both immediate and continuous medical device consulting to maintain project deliverables and product satisfaction.
See below for our medical device regulatory consulting services that are specific to the needs of startup companies.
- Regulatory strategy
- Global regulatory compliance and registration support
- FDA and other regulatory authority meetings
- FDA pre-submission meeting guidance
- Technical file development
- Person Responsible for Regulatory Compliance (EU MDR Article 15)
QUALITY MANAGEMENT
Implementing and maintaining an established and certified quality management system (QMS) safeguards your products and contributes to the credibility of your company. MedXfile’s team ensures all quality systems regulations are properly and sufficiently managed for reliable results.
Establishing a certified Quality Management System (QMS) is a critical requirement for manufacturing high integrity products. Yet, the process of upholding compliance with regulatory submissions demands detailed and ongoing advisement. Your QMS system needs to operate at full-capacity to safeguard and grow your company, that’s why our QMS consulting experts are equipped with the knowledge and experience to instill a first-rate, certified quality management system.
The MedXfile professionals monitor and study the ever-changing global quality and compliance requirements of international regulatory authorities, including the FDA and the EU medical device regulation.
We partner with clients to advise effective medical quality assurance (QA) management, such as ensuring products receive an ISO 13485 certification, meet the requirements for ISO 9001, and all other applicable product safety requirements. MedXfile provides you with a quality assurance consultant to advise and construct all components of a certified quality management system to guarantee compliance and build results.
MedXfile’s professionals are QMS consulting and quality assurance specialists that understand and assume each responsibility in order to establish a certified quality management system (QMS) for your company. Below are areas that our experts cover.
- Quality Management Systems (QMS) development, maintenance, improvement, and support.
- Drafting quality manual ISO 13485 and ISO 9001
- Electronic Medical Device Reporting (eMDR) & EU Vigilance Reporting System
- EU MDR strategic gap analysis
- ISO 13485 strategic gap analysis
- Third party ISO 13485 audits
- Selection and interpretation of US and international QMS requirements
- Audit for quality management system ISO 9001 & ISO 13485
- Conducting a strategic gap analysis
- Quality supplier audits