Medical Devices Regulatory Consulting Services

The global medical device market is expanding rapidly. At a CAGR of 6%, the market is expected to reach $1.15 trillion by 2034. The growth is driven by demographic shifts and innovations in digital space. Likewise, the regulatory environment for medical devices is becoming more complex and harmonized. The emphasis is more on AI, digital health, cyber security, and post-market surveillance. To capitalize on the market growth, it is a must for device manufacturers to be abreast with ever-evolving regulatory trends and procedures.

At Vigilare, we ensure that device manufacturers catch on the rapid market access with sustainable compliance. With expert medical device regulatory consulting support, we enable our customers embrace end-to-end compliance for their innovative device products and align with the most updated regulatory frameworks – FDA’s 21 CFR medical device amendments, EMA’s MDR and IVDR, CDSCO’s modernized GMP standards, PMDA’s approval processes, etc.

Vigilare’s Medical Device Regulatory Consultating Services

Publishing Services

At Vigilare, we specialize in preparing, formatting, and submitting regulatory documents that are mandatory for device approvals, which include:

CE Technical Files for Class I, II, and III devices, aligning with EU MDR requirements
CE Technical Files for Class A, B, C, and D devices, aligning with EU IVDR requirements
US FDA submissions like 510(k), PMA, HDE, and pre-submission applications

Regulatory Labeling & Technical Writing

From Instructions for Use (IFUs) to Unique Device Identification (UDI) and device labels, our technical writing adheres strictly to EU MDR, US FDA QSR, and other global standards. From a language requirements perspective, our team ensures that your product labeling complies with global and region-specific labeling standards focusing on clarity.

Medical Device Regulatory Compliance Consulting, Gap Analysis & Remediation

We evaluate Quality Management System (QMS), current technical file, dossier compilation, and technical documentation (e.g., ISO 13485, MDD/MDR, IVDR) identifying gaps against global requirements. Based on the identifications and gap analysis, our medical device regulatory consulting team provides technical guidance, and corrective actions and brings in remediation measures like risk management (ISO 14971) for full compliance.

QMS Compliance Services

At Vigilare, our medical device regulatory consulting experts assist you in designing, implementing, and maintaining a compliant Quality Management System (QMS). We extend our support for MDSAP, ISO 13485, audits, and documentation along with country-specific QMS requirements including certifications.

Medical Writing for Medical Device Submissions

Whether it’s compiling risk management plans (per ISO 14971), developing user manuals, quick start guides, clinical investigation of protocols, and reports, clinical summaries, software lifecycle documentation (IEC 62304), or documenting post-market surveillance reports, medical/ scientific writers at Vigilare ensure clarity, accuracy, and regulatory alignment. We also undertake writing services for Clinical Evaluation Reports (MEDDEV 2.7.1).

Medical Device Submissions and Registrations

Vigilare’s Medical Device regulatory consulting experts extend support for dossier preparation, compilation, and submission of technical files to health agencies. In addition, we optimize the data for each jurisdiction’s unique process and format. We assist manufacturers in understanding the product classification and gap analysis of the technical documentation and support them in conformance to local regulatory requirements, especially for CE marking (MDR/IVDR), 510(k), PMA, MHRA DeNovo, and TGA approvals.

MOH Interactions

Vigilare’s medical device regulatory consulting team is spread across the nations with a competitive edge to understand local nuances before going ahead with agency or MOH interactions. Leveraging our experience in managing regulatory agency communications, from pre-market consultations to audit responses and post-market commitments, we ensure effective and timely engagement with health authorities worldwide. We support device manufacturers with in-person meetings with MOH, decoding submission feedback and queries, and labeling and technical file translations.

Why Partner with Vigilare?

Medical device regulatory consulting experts with vast experience
Proven, flexible, and cost-effective service provision
Customized solutions for small and mid-sized medical device organizations
Global Health-authority-specific compliance expertise – USFDA, EMA, MHRA, CDSCO, etc.
360° Device Support, from QMS setup to post-market activities
Recognized for ISO 13485 expertise & compliance

Facts to Focus

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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.