For Medical Devices
Regulatory, Quality
and Clinical Solutions

Global Regulatory Compliance Consulting
(MDR, IVDR, FDA, SFDA, MDSAP, CANADA)
Comprehensive Business Partnership and Corporate Memory

20 Years in the Industry

Your Reliable Business Partner ERA MANAGEMENT

Legal
Compliance
Quality and Risk
Management
Strategic
Consultancy

EXPLORE OUR SERVICES

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ERA MANAGEMENT

Your Reliable Business Partner

At ERA Management, we provide our clients with reliable, independent, and confidential high-quality services in accordance with regulatory requirements.

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20+

Years of experience

With our expertise in the medical device industry, we contribute to the continuous development of manufacturers and partners.

SERVICES

Our Service Areas

We offer end-to-end support to medical device manufacturers, from clinical trials to laboratory testing, to help them access global markets.

Biomechanical tests examine the physical stresses to which medical devices are subjected during clinical use...
Subchronic systemic toxicity / ISO 10993-11, Histopathological examination...
Non-standard, customized analysis and aging tests for medical devices...
Sterility, bacterial endotoxin (LAL), bioburden...
In order to heal the broken areas of bone fractures...
Metal prostheses are used in cases where the hip joints have lost their function.
Total knee replacements consist of 3 parts, and the product...
Our primary testing methods for certifying the quality of your dental products are as follows:...
All necessary mechanical performance tests for your spinal implants...
Our updated Accreditation Certificate for 2025 has been published by IAS.
All the necessary performance for medical device coatings and...
Non-standard, customized analysis and aging tests for medical devices...

ERAY MANAGEMENT

WHY US?

Powerful and Sustainable Solutions

With our experience in the sector, we solve complex processes with customized and feasible models for your company.

With our experience in national and global projects, we maintain transparent communication with all stakeholders.

We offer simple, sustainable, and results-oriented consulting models tailored to your company's structure.

We strengthen your corporate memory by gathering technical and legal processes under one roof.

Confidence that comes with Expertise.

With over 20 years of experience, we simplify the compliance processes for medical device manufacturers to meet global standards and regulations.

Compliance with Legislation
Client Satisfaction
Sustainable System
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CUSTOMER REVIEWS

Perspective of Our Business Partners

CURRENT NEWS

Latest news from us.

You can follow global developments in the medical device industry, current regulatory announcements, and our trade show participation news here.