QUALITY & REGULATORY EXPERTISE

Clarity in complexity.
Confidence in compliance.

Helping medical device innovators navigate regulatory requirements — from EU MDR and CE marking to FDA 510(k) and global market access.

Discuss your project Explore our services

Based in NorwayEU & US regulatory support

CS-TRAN / MEDTECHPRECISION. PERSPECTIVE.

From evidence
to market access.

Expertise across the device lifecycle

EU MDRFDA 510(k)ISO 13485IEC 62304PRRC

ABOUT CS-TRAN

About us

CS-TRAN combines hands-on industry experience with a network of specialists, ensuring clients receive the right expertise for every regulatory and quality challenge.

Vision

To be a trusted regulatory partner, enabling MedTech companies to bring safe, compliant and innovative products to market efficiently.

Core Values

Customer Focus
Integrity
Technical Excellence
Collaboration
Pragmatic Solutions

OUR SERVICES

The right support.
At every stage.

From technical documentation and clinical evidence to quality systems and post-market obligations.

EUROPEAN MARKET

EU MDR &
CE marking

Technical documentation and clinical evidence support under EU MDR 2017/745, with support for clinical trials and post-market activities.

Literature search

Preparation and execution of a literature search protocol.

Clinical evaluation

Analysis and appraisal of data to prepare an MDR-compliant clinical evaluation.

Post-market surveillance

Planning and analysing post-market data to develop robust post-market documentation.

Technical file

Preparation of technical documentation according to EU MDR requirements across device classes.

Discuss EU market access

UNITED STATES MARKET

US FDA
510(k)

Preparation and submission of 510(k) premarket notification packages, with post-submission support through the FDA review process.

510(k) dossier

Predicate device identification, performance and biocompatibility testing guidance, dossier compilation, label review and submission.

Post-submission support

Support during FDA meetings, responses to review comments, interactive review meetings and supporting documentation.

Discuss FDA submission support

Quality. Governance. Global reach.

Practical support beyond the submission.

Quality management systems

QMS establishment and maintenance, and ISO 13485:2016 support.

Audits & management reviews

Internal audits, management reviews and preparation for external audits.

Risk, CAPA & suppliers

Risk management, corrective and preventive actions, and supplier audits.

PRRC services

Support from a Person Responsible for Regulatory Compliance under the MDR.

Global device registration

Registration support for India, Saudi Arabia, Australia, the UK and other markets.

EU authorised representative

Support with authorised representation and access to the European market.

THE PEOPLE BEHIND THE WORK

Specialist knowledge.
Shared perspective.

Regulatory specialists, medical doctors and quality engineers with experience across the medical device lifecycle.

TTQUALITY & REGULATORY

Toan Tran MSc

Senior Quality & Regulatory Specialist

Senior Quality & Regulatory Specialist with extensive experience across medical devices and pharmaceuticals. Former VP QA/RA at Epiguard AS and Quality Engineering Manager at Abbott Diagnostics. Expert in ISO 13485, ISO 14971, EU MDR 2017/745, Design Control, Validation, CAPA, Change Management, with over 25 years of hands-on leadership in regulated industries. PRRC and Lead Auditor ISO 13485.

EU MDRISO 13485PRRC

NRHEALTH TECHNOLOGY

Natale Rolim PhD

Health Technology & Innovation Expert

Expert in health technology innovation, EU-funded projects and strategic partnerships, with extensive experience supporting MedTech companies from concept to commercialization. Specialised in project development, regulatory compliance for medical devices and Software as a Medical Device (SaMD), clinical project oversight, and innovation strategy. Experienced in building international collaborations that accelerate product development and market access. ISO 27001 Lead Auditor Certified. Advisor at Norway Health Tech

InnovationClinical projectsISO 27001

JTCLINICAL & MEDICAL

Joyce Sesilie Timberlid MD

Medical Doctor & MedTech Advisor

Medical doctor with MedTech experience supporting Medical Device development and lifecycle activities under MDR 2017/745 and ISO 13485 frameworks. Strong expertise in clinical evaluation, medical affairs, risk management, and alignment of clinical practice with regulatory, quality, and post-market requirements within health technology environments

Clinical evaluationMedical affairs

KSMEDICAL DEVICE SOFTWARE

Kenneth Shaw MSc

Regulatory & Quality Specialist

Regulatory and Quality Specialist in Medical Device Software (MDSW), Software as a Medical Device (SaMD), AI-enabled medical devices (AIaMD) and software-driven IVDs. Over 10 years of experience guiding software products from concept and development through CE marking and post-market surveillance. Specialised in IEC 62304, IEC 82304-1, software risk management, cybersecurity, and regulatory compliance under the EU MDR, IVDR and EU AI Act, helping MedTech companies develop safe, compliant and market-ready software solutions

IEC 62304SaMDAI Act

WE UNDERSTAND YOUR CHALLENGES

Less uncertainty.
More progress.

We know the demands of bringing a medical device to market. Our services address the work that can slow you down.

Talk through your challenges

Time-consuming literature searches

Finding and appraising the relevant evidence.

Limited internal resources

Covering quality and regulatory work with the right expertise.

A changing regulatory landscape

Interpreting MDR requirements and relevant guidance.

High costs & time investment

Planning clinical evaluation work and resources.

Complex documentation

Building documentation aligned with MDR and MDCG guidance.

ISO 13485 certification preparation

Developing the quality system and supporting documentation.

LET'S TALK

Your next step
starts with a
conversation.

Tell us where you are and what you need. We'll help outline a clear, budgeted path forward.

info@cs-tran.no +47 400 45 942

Clarity in complexity.Confidence in compliance.