SOLUTIONARY MD
Our Services
Regulatory Strategy Development
Developing a comprehensive regulatory strategy that includes identifying the relevant regulatory requirements and guidance documents applicable to the device and determining the appropriate regulatory pathway to obtain clearance/approval.
EU MDR Technical Documentation Preparation
Reviewing the client's existing technical documentation to identify required updates to comply with the EU MDR requirements. We can either support the client through the update process or provide technical writing services to update or create new, compliant documentation.
Regulatory Submissions
Preparing and submitting regulatory documentation to regulatory agencies, such as FDA 510(k) submissions, CE marking applications, and more.
Training
Providing training to company personnel on regulatory requirements, quality system development and implementation, and other relevant topics.
QMS Development and Implementation
Developing and implementing a QMS that complies with applicable regulations and standards, such as ISO 13485, FDA Quality System Regulation (QSR), Canadian MDSAP.
Audit and Inspection Preparation
Preparing for regulatory audits and inspections, such as FDA inspections, Notified Body audits, etc., including conducting mock audits to identify potential issues and develop corrective actions.
Additional Services
Compliance Gap Analysis, Post-Market Surveillance support, Labeling and Marketing Review, Sterilization Validation, Biological Evaluation reports, Communication with regulatory bodies, and more.