Technical & Clinical Writing

REGULATORY STRATEGY

Precise. Compliant. Strategic.

At AKRA TEAM, we translate complex scientific, clinical, and regulatory information into clear, defensible, and audit‑ready documentation. Our technical and clinical writing services support EU and US regulatory pathways, enabling medical device and IVD manufacturers to meet MDR, IVDR, and FDA requirements with confidence — from early development through post‑market activities.

We work at the intersection of science, regulation, and strategy, delivering documentation that withstands regulatory scrutiny while supporting efficient submissions, successful conformity assessments, and long‑term product sustainability

CLINICAL EVIDENCE

Clinical & Performance Evaluation

We provide end‑to‑end clinical and performance evaluation support, including drafting, revision, remediation, and lifecycle maintenance of Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Performance Evaluation Plans (PEP), Performance Evaluation Reports (PER), Periodic Safety Update Reports (PSUR), and Summary of Safety and Clinical/Performance (SSCP/SSP).

Our services include systematic literature searches conducted across major scientific and medical databases, with transparent methodologies and robust appraisal aligned to MDR Annex XIV, IVDR requirements, MEDDEV guidance, and current MDCG expectations.

MARKET SURVEILLANCE

Post‑Market Surveillance (PMS)

AKRA TEAM delivers comprehensive post‑market surveillance solutions designed to support regulatory compliance and proactive risk management. We develop fully compliant PMS Plans, perform structured data analysis, and support PMCF and PMPF planning, ensuring alignment with MDR/IVDR lifecycle obligations.

Our PMS documentation integrates vigilance data, complaint trending, clinical feedback, and benefit‑risk analysis to support ongoing market access and notified body engagement.

TECHNICAL SOLUTIONS

Technical Documentation

We provide structured Technical Documentation (TD) writing services that support conformity assessment, technical file remediation, and inspection readiness. Our experts assist with pre‑clinical testing strategy, test planning, and evidence alignment across risk management, biological safety, performance, and clinical data.

All documentation is developed with a clear understanding of notified body expectations, helping reduce review cycles and minimize regulatory friction.

Clinical Investigation & Performance Studies

Our team supports pre‑market and post‑market clinical investigations and performance studies through expert protocol and report writing. We ensure documentation is aligned with ISO 14155, regulatory guidance, and ethical expectations, while maintaining scientific rigor and consistency across submission dossiers.

FDA Submissions

AKRA TEAM prepares complete and strategic FDA submissions, including 510(k)s, PMAs, Q‑Submissions, and 513(g) requests. All supporting technical and clinical documentation is managed in‑house, ensuring seamless integration across regulatory narratives and a clear, reviewer‑focused submission strategy.