Regulatory Publishing Services for Medical Devices

Regulatory publishing services for medical devices refer to compiling, formatting, and documenting the regulatory submission dossier required for ongoing compliance requirements and product approvals in global markets. Given the stringent regulated landscape of MedTech, device manufacturers must give highest priority to submission accuracy and formatting excellence to enable easy reviews.

Vigilare’s Regulatory Publishing Services for Medical Devices

CE Technical File Preparation (EU MDR)

CE technical file is critical to demonstrate device safety, performance, and compliance with EU MDR. To prepare the CE technical file, our publishing experts at Vigilare assist with collating and structuring the documents (as per Annex II & III requirements), preparing Clinical Evaluation Reports (CER), and formats and evaluating the dossier readiness for final review by the notified body or Health Authority.

510(k), PMA, De-Novo, IDE, HDE & Pre-submission applications for US FDA

With unparallel knowledge of FDA’s evolving device regulations and eCopy formats, Vigilare helps device manufacturers meticulously prepare applications, such as:

510(k) for equivalence submission for class II devices,
Premarket applications (PMAs) for Class III and high-risk devices
De-Novo application for novel device’s new classification requests
Investigation Device Exemption (IDE) applications during clinical trials
Humanitarian Device Exemption (HDE) applications for rare diseases
Pre-submission applications for early interaction packages with the FDA

Testimonials

Partnering with Vigilare for pharmacovigilance services has been a game-changer. Their team is proactive, detail-oriented, and consistently on top of safety updates and regulatory changes across Europe. It’s rare to find such a dependable partner who treats compliance as seriously as we do.

We rely on Vigilare for global pharmacovigilance support across multiple regions. They understand the nuances of each market and consistently deliver accurate, timely, and compliant safety reporting. It’s been a relief having such a competent team on board.

Vigilare’s post-marketing support has helped us maintain compliance seamlessly in the US market. Their responsiveness and structured reporting systems made it easy to keep pace with regulatory expectations. Their clarity and ownership stand out.

We engaged Vigilare during a critical vaccine rollout phase. Their insights into regulatory processes in the Middle East, combined with their ability to coordinate across regions, ensured smooth approvals and timely submissions. They truly acted like an extension of our team.

Vigilare has been instrumental in supporting our medical device registrations in both the US and European markets. From preparing the technical documentation to navigating CE and FDA submissions, their expertise made a complex process feel manageable and well-guided.