We can help no matter your situation

Getting started and not sure what you need? We can help you navigate the intricacies of the regulations, supporting you at every point along your path.  From driving product innovation and devising regulatory strategies to implementing design controls and risk management through clinical evaluation, submissions, and quality management system as well as post market activities.

Major ISO or CE Mark Findings strategy and management, our experienced staff has been on both sides of the table when it comes to audits and audit findings

• We can help with planning and developing your response

• We can help with identifying the root cause and corrective actions

• We can help implement the corrective actions

FDA or ISO audit front-room and back-room assistance – FDA inspections are stressful whether announced or unannounced, our staff has experience interacting with the FDA

• We can help you prepare documents and records in the back room

• We can help prepare your subject matter experts before they enter the front-room and interact with the inspector / auditor

• We can provide guidance to help keep you compliant

Vigilance and Adverse Event strategy and correspondence

• We can help you determine if the incident meets reporting requirements

• We can help  you prepare the vigilance or regulatory report

• We can help with submitting the initial, interim and final reports to the appropriate regulatory authorities

Field Safety Corrective Actions and recall strategy and management

• We can help you with the health hazard assessment

• We can help you with the overall strategy for the recall or FSCA

• We can help with submitting the initial, interim and final reports to the appropriate regulatory authorities