Medical Device and IVDs
Medical Device and IVDs: Empowering Healthcare Through Innovation
Medical devices are essential tools used in modern healthcare for various purposes,
including diagnosis, prevention, monitoring, treatment, and symptom alleviation. They range from
simple instruments like tongue depressors and bandages to complex machines like pacemakers and
artificial limbs. In vitro diagnostic (IVDs) medical devices are a type of medical device that
examines samples taken outside the living body, such as blood, tissue, or other fluids, to
determine a person’s health. Examples of IVDs include pregnancy tests, blood sugar tests,
cholesterol tests, tissue biopsies, and genetic tests.
Regulatory Compliance
Regulations for both medical device & IVDs ensure their safety and effectiveness, typically involving pre-market approval and post-market surveillance. These regulations vary depending on the country but typically involve pre-market approval and post-market surveillance.
The importance of medical devices and IVDs lies in their ability to enable earlier and more accurate diagnosis, improved disease monitoring, development of new treatments, and improved quality of life for patients.
The field of medical devices and IVDs is constantly evolving, with new technologies emerging to further improve healthcare and patient outcomes. As new technologies emerge, the promise of further improvements in healthcare and patient outcomes is immense.
Supplier Audits1. We conduct pre-qualification audits to assess a supplier's ability to meet the quality requirements before awarding contracts.
2. We perform ongoing supplier audits to ensure they continue to comply with the specifications and regulatory standards.
3. Our audits cover all aspects of the supplier's QMS, including quality control, documentation, and recordkeeping.
Internal Audits1. We conduct internal audits to evaluate the effectiveness of the existing QMS and identify areas for improvement.
2. Our audits are tailored to the specific needs and risks, ensuring they address the critical processes and procedures..
3. We provide comprehensive audit reports with detailed findings, recommendations, and corrective action plans.
Lead Auditor Support1. We can train and mentor the internal staff to become qualified lead auditors, empowering them to conduct internal audits independently.
2. We offer on-site support during the internal audits, providing guidance and expertise.
3.This increases the audit efficiency and effectiveness, while building the team's internal capabilities.
Process and Procedure Validation1. We assist in validating the critical processes and procedures to ensure they consistently meet the quality requirements.
2. We use recognized validation methodologies and provide documented evidence to support the validation activities.
3. This helps the demonstrate compliance with regulatory requirements and ensure the reliability of the processes.
Document Compiling and Writing1. We assist in compiling and writing the necessary documentation for obtaining ISO 13485 and ISO 9001 certifications.
2. Our team has extensive experience in medical device regulations and standards, ensuring the documentation is accurate, complete, and compliant.
3.We also offer ongoing support to maintain and update the documentation as the QMS evolves.
Gap Analysis1. We conduct gap analyses to assess the compliance of the existing quality system with relevant standards and regulations.
2. We identify areas where the system needs improvement to achieve certification or maintain compliance.
3. This helps to prioritize the corrective actions and develop a clear roadmap for improvement.
OMC Services
Why Choose OMC?
Our commitment to quality and excellence sets us apart
Expert Team Our team consists of regulatory experts with extensive industry experience.
Global Reach We provide regulatory support across multiple international markets.
Quality Assurance We maintain rigorous quality standards in all our processes and services.
Proven Results Our track record demonstrates successful outcomes for our clients.
Client-Focused We prioritize your needs and provide tailored solutions for your business.
Timely Delivery We understand the importance of time-to-market and work efficiently.
Ready to Streamline Your Regulatory Compliance?
Join hundreds of companies who trust OMC Medical for their regulatory needs.
