Compliance made simple,
scalable, and smart
We guide MedTech, Life Sciences, and Digital Health companies through the full regulatory lifecycle: from validation to certification and
post-market excellence.
We support medical device companies in navigating an increasingly complex regulatory landscape, ensuring full compliance
and streamlining clinical research.
Core Services
Gap Analysis & Assessment
We start with a structured initial assessment of your Quality Management System and regulatory documentation to understand your current level of compliance.
Our team reviews existing materials, identifies regulatory gaps, and defines a clear implementation roadmap aligned with regulatory requirements.
- Initial assessment & document review
Review of existing QMS documentation and related processes. - Gap Analysis report
Detailed identification of compliance gaps and areas for improvement. - Implementation roadmap
Strategic timeline including priorities, milestones, and resource planning.
- Quality manual development
Creation of the top-level documentation defining the QMS structure. - SOP Development / Adaptation
Development or optimization of Standard Operating Procedures. - Training delivery
Training programs delivered on-site or remotely to ensure effective adoption. - CAPA and document control systems
Implementation of corrective action processes and document management systems.
QMS Implementation (ISO 13485)
We support the development and implementation of a Quality Management System compliant with ISO 13485, tailored to the size and structure of your organization.
Our approach focuses on building practical and sustainable quality processes that integrate smoothly with daily operations.
Technical file / Technical documentation
We assist companies in preparing the technical documentation required for regulatory compliance, ensuring that device safety, performance, and design are properly documented.
- Device Master Record (DMR)
Complete documentation of device specifications and production information. - Clinical Evaluation Report (CER)
Evaluation and analysis of clinical data supporting device safety and performance. - Software documentation (IEC 62304)
Preparation of software lifecycle documentation for software-based devices. - Risk management file
Documentation aligned with ISO 14971 risk management requirements.
- Classification justification
Regulatory rationale supporting device classification. - GSPR Checklist completion
Preparation of the General Safety and Performance Requirements checklist. - Declaration of Conformity (DoC)
Support in drafting the Declaration of Conformity. - Notified Body liaison
Ongoing communication and support during interactions with the Notified Body.
CE Marking support (MDR)
We guide manufacturers through the CE marking process under MDR, ensuring that regulatory documentation and processes meet the expectations of Notified Bodies.
Additional services
We also provide complementary regulatory support to strengthen compliance and operational readiness.
- Supplier audit support
Supplier assessment and audit preparation. - Design verification and validation
Support in planning and executing verification and validation activities. - Expert advisory services
Regulatory expertise available on a consulting or per-diem basis.
Focus areas
SaMD developers
Regulatory support for Software as a Medical Device (SaMD), covering the full development and compliance lifecycle.
This includes implementation of IEC 62304 software lifecycle processes, cybersecurity considerations, risk management according to ISO 14971, and preparation of clinical evaluation documentation.
Support typically spans from initial gap analysis through certification, depending on device readiness.
Virtual manufacturers
Support for companies operating as virtual manufacturers, managing supply chains without owning production facilities.
Services include supplier oversight, design control implementation, and development of ISO 13485-compliant quality systems adapted to lean organizational structures.
Medical device producers
Regulatory and documentation support for medical device manufacturers across all device classes, including legacy devices transitioning to MDR.
Services include preparation of technical documentation, interaction with Notified Bodies, and implementation of post-market surveillance processes.