Premier quality and 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.
Comprehensive medical device compliance support
for US and EU markets
- Regulatory strategy development
- CE submission - MDR conformity assessment support (CE mark) with a comprehensive technical file
- FDA clearance (510k)
- Clinical evaluation strategy and planning
- Clinical study execution
- Medical advisory services
- Direct clinical access
- QMS strategy and setup
- ISO 13485:2016, MDR, and FDA compliance
- Audits (internal, supplier, and management reviews)
- Notified Body selection and contracting
- Training programs
- Concept feasibility
- Design Control
- Qualification and validation
- Risk Management
- Biological evaluation strategy and plan
- Biocompatibility study - selecting and monitoring laboratory
- Biological evaluation summary and report
- Sterilization
- Software development and testing
- Software validation
- Risk assessment
- Validation
- 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
- 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
- Preparation of Post-Market Surveillance Plan
- Periodic safety update report
- Post-Market clinical follow up
- PRRC service
Development of regulatory strategy compliant with US FDA and EU MDR (CE Mark) regulations.
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.
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.
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.
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.
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 competencies
in Quality and Regulatory Advisory
Services
Our core competencies
in Quality and Regulatory Advisory Services
Expertise
Profound comprehension of quality and compliance guidelines.
Efficiency
Proficiency in gap analysis for effective budgeting and time estimations.
Acquaintance
Extensive familiarity with the approval processes.
Mastery
Knowledgeability in specific product domains, providing impartial advice on the best regulatory strategy.
Comprehensiveness
Comprehensive management of the product life-cycle for market success and consistent excellence.