Quality & Regulatory Advisory Services
for Medical Devices

In the medical device sector, quality is paramount. As a company specializing in medical device technology, we maintain rigorous standards of quality throughout our research, development, and production stages.We adhere to established standards including ISO 13485 and FDA regulations for medical device technology.

View our ISO Certificate

Our premier QA/RA services

Client

Our mission is to help our partners achieve compliance in the medical device industry. We support our partners in placing compliant medical devices on the market, assisting them throughout the design and development process, as well as monitoring the devices once they are on the market.

Status evaluation audit

We aim to understand our partner’s needs and current status, ensuring that the most efficient service is provided.

Regulatory

We help place compliant medical devices on the market, managing and supporting both pre- and post-market phases. Our services include:

Regulatory strategy development
CE submission – MDR conformity assessment support (CE mark) with a comprehensive technical file
FDA clearance (510k)

Clinical evaluation

From literature research to clinical studies with direct physician and clinical access, we assist our partners in the followings:

Clinical evaluation strategy and planning
Clinical study execution
Medical advisory services
Direct clinical access

Quality Management

We offer expert advice and provide a fast path to a highly efficient Quality Management System, tailored to our partner’s goals and ensuring the system is audit-ready. Our services include:

QMS strategy and setup
ISO 13485:2016, MDR, and FDA compliance
Audits (internal, supplier, and management reviews)
Notified Body selection and contracting
Training programs

Design and development

We advise our partners throughout their design and development objectives to ensure compliance with medical device requirements from concept to market, covering areas such as

Concept feasibility
Design Control
Qualification and validation
Risk Management

Biological evaluation

To determine the biological risk of a medical device, a thorough biological evaluation is required, including aspects such as:

Biological evaluation strategy and plan
Biocompatibility study – selecting and monitoring laboratory
Biological evaluation summary and report
Sterilization

Cybersecurity evaluation & Software development

We provide reliable software solutions for medical devices, while conducting comprehensive cybersecurity risk assessments to ensure secure and compliant performance:

Software development and testing
Software validation
Risk assessment
Validation

CE mark or FDA clearance

We support our partners in placing compliant medical devices on the EU and U.S. markets by assisting with the followings:

Registration procedure
Technical Documentation compilation in accordance with MDR requirements
Preparation of FDA compliant (510k) documentation
Submission and certification procedure
Authority and Notified Body contact

CE mark or FDA clearance

We support our partners in placing compliant medical devices on the EU and U.S. markets by assisting with the followings:

Registration procedure
Technical Documentation compilation in accordance with MDR requirements
Preparation of FDA compliant (510k) documentation
Submission and certification procedure
Authority and Notified Body contact

Post Market Surveillance

It will be available from 2025 and will include the following offerings:

Preparation of Post-Market Surveillance Plan
Periodic safety update report
Post-Market clinical follow up
PRRC service

Client

Our mission is to help our partners achieve compliance in the medical device industry. We support our partners in placing compliant medical devices on the market, assisting them throughout the design and development process, as well as monitoring the devices once they are on the market.
Status evaluation audit

We aim to understand our partner’s needs and current status, ensuring that the most efficient service is provided.
Regulatory
We help place compliant medical devices on the market, managing and supporting both pre- and post-market phases. Our services include:
- Regulatory strategy development
- CE submission – MDR conformity assessment support (CE mark) with a comprehensive technical file
- FDA clearance (510k)
Clinical evaluation
From literature research to clinical studies with direct physician and clinical access, we assist our partners in the followings:
- Clinical evaluation strategy and planning
- Clinical study execution
- Medical advisory services
- Direct clinical access
Quality Management
We offer expert advice and provide a fast path to a highly efficient Quality Management System, tailored to our partner’s goals and ensuring the system is audit-ready. Our services include:
- QMS strategy and setup
- ISO 13485:2016, MDR, and FDA compliance
- Audits (internal, supplier, and management reviews)
- Notified Body selection and contracting
- Training programs
Design and development
We advise our partners throughout their design and development objectives to ensure compliance with medical device requirements from concept to market, covering areas such as
- Concept feasibility
- Design Control
- Qualification and validation
- Risk Management
Biological evaluation
To determine the biological risk of a medical device, a thorough biological evaluation is required, including aspects such as:
- Biological evaluation strategy and plan
- Biocompatibility study – selecting and monitoring laboratory
- Biological evaluation summary and report
- Sterilization
Cybersecurity evaluation & Software development
We provide reliable software solutions for medical devices, while conducting comprehensive cybersecurity risk assessments to ensure secure and compliant performance:
- Software development and testing
- Software validation
- Risk assessment
- Validation
CE mark or FDA clearance
We support our partners in placing compliant medical devices on the EU and U.S. markets by assisting with the followings:
- Registration procedure
- Technical Documentation compilation in accordance with MDR requirements
- Preparation of FDA compliant (510k) documentation
- Submission and certification procedure
- Authority and Notified Body contact
Post Market Surveillance
It will be available from 2025 and will include the following offerings:
- Preparation of Post-Market Surveillance Plan
- Periodic safety update report
- Post-Market clinical follow up
- PRRC service

Regulatory strategy

Development of regulatory strategy compliant with US FDA and EU MDR (CE Mark) regulations.

Quality management

For companies seeking assistance in establishing a quality management system, MedRes serves as a proficient partner. We provide guidance on quality and regulation, especially in Research & Development, Manufacturing, and Quality Assurance.

In our case, the creation, enhancement, and audit of QMSs is not only documented but also consistently executed, promoting operational effectiveness and notable device quality. For businesses aiming for a global presence, we offer guidance in crafting a QMS that aligns with international benchmarks, including ISO 13485 and 21CFR part 820.

Technical documentation

Adhering to specific national regulations is vital for obtaining market approval. MedRes stands ready to assist with training, documentation templates, addressing audit deviations, or crafting essential documents.

Risk management

It is imperative for manufacturers to maintain a documented risk management structure. The assessment of medical device risks follows the ISO 14971 standards. MedRes supports customers in formulating a risk management framework that aligns with ISO 14971 and guides the risk evaluations to ensure compliance in a cost-effective and efficient manner.

Clinical evaluation

Medical device assessments require detailed technical documentation and clinical evaluations. Navigating the evolving guidelines can be challenging. Utilizing expertise to guarantee all prerequisites are satisfied is a worthwhile investment. MedRes provides tailored services, which range from updating literature reviews to expert guidance for internal evaluations and addressing deviations identified by your Notified Body, FDA or other regulatory agency.

Qualification and validation

Both qualification and validation are pivotal for quality management in medical device manufacturing. We support clients in integrating these methods into their quality systems, pinpointing equipment and processes that require or can benefit from qualification/validation for quality improvement or strategic objectives.

Our core pillars

Expertise

Profound comprehension of quality and compliance guidelines.

Efficiency

Proficiency in gap analysis for effective budgeting and time estimations.

Comprehensiveness

Comprehensive management of the product life-cycle for market success and consistent excellence.

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