ISO 13485 & MDR 2017/745

Medical Device Regulatory Consultancy

Expert support for your ISO 13485 and MDR 2017/745 compliance processes

CE MarkingClinical EvaluationRisk Management

PHA Consultancy

Medical Device Regulatory Excellence

ISO 13485

MDR

CE Mark

QMS

Risk Mgmt

Clinical

Our Services

Comprehensive consultancy services in the medical device industry

ISO 13485 Consultancy

We help you establish and maintain your quality management system in accordance with international standards.

MDR 2017/745 Compliance

We provide comprehensive support to meet European Medical Device Regulation requirements.

Technical Documentation

We professionally prepare the technical documentation required for CE marking.

Clinical Evaluation

We offer expert support for clinical evaluation reports and clinical investigation planning.

Risk Management

We structure your risk management processes in accordance with ISO 14971 standard.

Training & Seminars

We provide customized training to keep your team's regulatory knowledge up to date.

Why PHA Consultancy?

15+

Years Experience

200+

Clients

98%

Success Rate

Global Network

Client Testimonials

Hear from our satisfied clients

“Thanks to PHA Consultancy, we successfully completed our MDR compliance process. Their professional approach and deep industry knowledge helped us obtain our CE marking smoothly.”

Dr. Ayse Yilmaz

MedTech Solutions

“PHA team's support during the ISO 13485 certification process was invaluable. They were with us at every stage.”

Mehmet Kaya

BioDevice GmbH

“The consultancy we received on technical file preparation accelerated our products' entry into the EU market.”

Sarah Johnson

Nordic Medical Devices

Accelerate Your Regulatory Processes

Contact our expert team and simplify your medical device compliance processes.