Comprehensive technical documentation service supporting medical device regulatory compliance. Includes literature search reports, clinical and performance evaluations, biological assessments, usability engineering documents, risk management files, post-market surveillance plans, and periodic safety...
Manufactured by
BioTop Medical Dr. Teresa Lopes
Leiden, Netherlands
We provide hands-on assistance in both, pre- and post-market activities. This means in summary (but not limited to): Device classification Interpretation and identification of the product-applicable regulatory and standard requirements Development, implementation and maintenance of the company quality management system to: Writing / organizing the Device History File Writing / organizing the Technical Documentation File Performing and reporting/documenting the post-market surveillance activities. Our level of involvement is determined by your needs . We can: Provide advice, coaching or project management; Review quality and regulatory documents or write the documents; Perform supplier and internal audits; Take up functions as dedicated as a QA/RA Manager or Quality Officer or be the PRRC for your company.
✦ Product-Specific Coverage
Based on AI-matched alternatives related to this product across Suplivia's medical sourcing network.
Generated for this product
AI-matched supplier coverage based on related product alternatives.
Maven Profcon Services LLP
India · 18 relevant products
Abingdon Health plc
United Kingdom · 1 relevant product
CERTEAFILES SAS
France · 2 relevant products
66 more relevant manufacturers available
Get free access to all relevant manufacturers for this product.
See all manufacturers →12 more sourcing countries available
Get free access to all sourcing countries identified for this product.
See all countries →See the full supplier coverage for this product
Get free access to all relevant manufacturers, sourcing countries, and product alternatives.
✓ Free for medical industry professionals.
from other manufacturers
from other manufacturers
3 of 108 closest product alternatives
Maven Profcon Services LLP · India
Regulatory consulting service supporting medical device manufacturers with UKCA marking compliance, technical documentation preparation, MHRA registration, conformity assessment, and UK labeling requirements for devices and in vitro diagnostics.
Abingdon Health plc · United Kingdom
Comprehensive technical file preparation services for in vitro diagnostic devices supporting regulatory submissions and compliance documentation requirements.
CERTEAFILES SAS · France
Software platform for creating and managing MDR-compliant technical documentation for medical devices. Automates regulatory file generation, performs real-time compliance checks, and maintains product documentation throughout the device lifecycle. Includes consulting services for regulatory strategy and auditing support.
105 more product alternatives available
Create a free account to compare more product alternatives and supplier options.
© 2026 Suplivia · Home · Browse Products