Regulatory Compliance Consulting, Gap Analysis and Remediation

How accurate is your Quality Management System (QMS)? Have you evaluated its audit readiness? In a highly regulated landscape of medical devices, checking and ensuring on quality of your processes is mandatory. Be it technical documentation, standard procedures, facility well-being, or simple SOPs. Manufacturers must proactively evaluate and assess all the aspects before filing an application. They should evaluate and identify the gaps and chalk out remediation plans for successful audits and easy market access.

As an end-to-end regulatory compliance consulting partner, we at Vigilare evaluate your QMS, current technical file, dossier compilation, and technical documentation (e.g., ISO 13485, MDD/MDR, IVDR) identifying gaps against global requirements. Based on regulatory gap analysis and identifications, our team provides technical guidance, and corrective actions and brings in remediation measures like risk management (ISO 14971) for full compliance.

Vigilare’s Regulatory Compliance Consulting, Gap Analysis Expertise

QMS documentation – Review for Audit compliance, and Remediation Plans

Quality Management System (QMS) is crucial for obtaining compliance. QMS framework and documentation should be audit-ready, and cleared of all the gaps and vulnerabilities and aligned with ISO and other regional health authority standards. To ensure the QMS framework is in line, we at Vigilare, undertake:

Regulatory gap analysis of records and policies
Mock inspections to check audit readiness
Chalk out remediation plans based on the audit findings
Integration of risk management plans
Support CAPA

MDSAP/ ISO 13485 audits and documentation

The Medical Device Single Audit Program (MDSAP) is an audit program that enables manufacturers to satisfy compliance requirements of different jurisdictions like Australia, Brazil, Canada, Japan, and the U.S. It is a two-stage audit process, where the first stage includes readiness of QMS documentation and the second one focusses on on-site assessment of QMS implementation. Recently, Canada mandated MDSAP for Class II devices. At Vigilare, we assist manufacturers with:

Internal and external MDSAP audits
Gap identification across the participating jurisdictions
Compilation of required QMS documentation.

Country-specific QMS compliance consulting and certification

Though Quality Management System (QMS) requirements are being harmonized globally, there are unique regional requirements in some countries. We guide device manufacturers to comply with region-specific QMS standards as well. For example,

FDA QMSR
EU MDR (2017/745) and IVDR (2017/746)

NMPA QMS

Facts to Focus

Device Applications

0 K

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.