Top Management’s Responsibility for Risk Management in Medical Device Manufacturing...
ISO 45001:2018 Occupational Health and Safety
ISO 45001 aims to help organizations improve their...
21 CFR (FDA) and (EU) MDR Standards
This webinar takes a "birds-eye-view" of 21 CFR...
Certifying to ISO 13485 & Global Medical Device Regulatory Requirements
The MDSAP is growing...
ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO is the International Organization for Standardization (www.iso.org), an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards, headquartered in Geneva, Switzerland. Requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size and can be used by any organization involved in one or more stage(s) of the life-cycle of a medical device.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for QMSs. Compliance with ISO 13485 is often recognized as the first step in achieving compliance with regulatory requirements. The 2016 version of the standard has as its goal that it "provide an easily understood Quality Management System (QMS) standard that is designed for REGULATORY purposes." The ISO 13485 is embraced both by the FDA and the European regulatory bodies. Omnex specializes in implementations where the FDA 21 CFR 820 regulatory requirements and the European Union Medical Device regulation are integrated into the ISO 13485 QMS. We have also implemented management systems that included Japanese and Canadian regulatory requirements. Organizations that want to integrate multiple regulatory requirements and achieve compliance with US, Canadian, Brazilian, Japan and Australian regulations can look at MDSAP. See below.
Learn from Omnex's QMS experts on how to implement and/or audit ISO 13485 systems including risk management methodology with Best In Class methods. See Webinars on ISO 13485 and MDSAP.
The Medical Device Single Audit Program (MDSAP) was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and their respective regulatory requirements.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.
The FDA along with Therapeutic Goods Administration of Australia, Brazil's Agencia Nacional de Vigilancia Sanitaria, Health Canada, Japan's Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) will be participating in a MDSAP Pilot. The FDA will accept the MDSAP audit reports as a substitute for routine Agency inspections. MDSAP audit will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.
Omnex specializes in implementing MDSAP programs that integrate ISO 13485 along with multiple regulatory requirements of agencies worldwide. Contact Us for more information on how Omnex can help your organization.
ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services consistently.
Omnex specializes in implementing MDSAP programs that integrate ISO 13485 along with multiple regulatory requirements of agencies worldwide.
Supply Chain Management
Omnex's Supply Chain Management Practices include a number of different initiatives and improvements we have conducted for many different sectors from Automotive, Aerospace, Medical Devices, Power, Semiconductors/Hi Tech and others.
We have conducted Supplier Capability Improvement in Management Systems, APQP and PPAP, FMEA, Lean and Six Sigma, Zero Defects over our 35 year history. If you look at each of these different practices you will find the Omnex team has the depth to provide you global assistance for your supply bases.
Lean - Agile Product Development, ISO 14971 Risk Management including APQP & Coretools
Omnex helps improve your New Product Development Process (APQP and Core Tools) that further improves new product launch Quality and Timing. Let us help you improve linkages of the DFMEA, DVP&R (test plans), Process Flow, PFMEA, Control Plan and Shop Floor instructions with Omnex's Digital Collaboration Platform with our training and implementation.
We will help streamline your process, improve linkages, provide training and workshops and digitalize New Product Development.
Lean Six Sigma Strategy and IoT
The goal of Lean and Six Sigma programs is Quality and cost savings. Lean programs will improve Productivity, Cost, Lead Time, Inventory and Space usage by 20% to 50% in each Kaizen. Six Sigma Black Belt programs will on an average save 1.25 to 2.5 Million per program.
We will assist you while the overall goal is to help you continue the program on your own with some Omnex continued assistance.
Problem Solving and Statistical Tools
Omnex conducts Disciplined Problem Solving in a number of methodologies including 8D, Root Cause Analysis and 5 Why. Omnex principals help write a methodology for problem solving called "EPS or Effective Problem Solving" for the AIAG. Our experience in problem solving goes back 30 years. We have helped a number of organizations implement and maintain a culture of problem solving.
Omnex recommends training for top management, Facilitator competency and coaching, Company-wide training, E-learning, and Problem Solving Software as a part of the solution to develop a problem-solving culture within the organization.
ISO 27001:2018 Cybersecurity
Omnex is a member of many of the ISO Technical committees that write the ISO 9001, ISO 14001, and ISO 45001 standards. Omnex principals were also the writers of the core tools standards (APQP, FMEA, SPC, MSA, and PPAP) and AAQG writing committee for AS9100D.
Omnex provides a variety of services for Management Systems in the Medical Devices industry such as Training and Competency Development, Implementation and Coaching, Software Digital Platforms, and Outsourcing.
ISO 26000 Social Responsibility & Sustainability
ISO 26000 is a guidance document for Social Responsibility. It defines Social Responsibility as the responsibility of an organization to study the impact of its decisions and activities on society, environment through transparent and ethical behavior. It contributes to health and welfare of society through sustainable development.
Social Responsibility is at a cross section of environment, health and safety of its employees, ethical behavior and sustainable development. Omnex integrates social responsibility & sustainability to an integrated management system.
21 CFR (FDA) and (EU) MDR Standards
This webinar takes a "birds-eye-view" of what the different parts of 21 CFR are, as they apply to Medical Device Manufacturing...
ISO 45001:2018 Occupational Health & Safety
ISO 45001:2018, Occupational Health and Safety standard under International Organization...
The Medical Device Risk Management Standard - What’s New with ISO 14971:2019
Risk management plays a prominent role in the development of medical devices...
Certifying to ISO 13485 and Global Medical Devices Regulatory Requirements - MDSAP
The MDSAP is growing in popularity in the medical devices industry...
Medical Devices Clients
- Abbott Laboratories
- Catalent Pharma Solutions
- Centor Rx
- Draegar Medical Systems
- Formulated Solutions
- General Scientific
- Glenwood Laboratories
- Hologic Surgical Products
- ICU Medical
- Johnson Matthey
- Karl Storz Endoscopy
- Micro Machine
- Novo Surgical
- Orthomerica Products
- Pari Respiratory
- Reshape Life Sciences
- Scitech Medical
- Silicon Microstructures
- TDK Corporation
- Zeman Manufacturing
- Zimmer Biomet
How Can We Help You...
For any service request or to seek consulting, Our Customer Service Team is ready to serve you, round the clock.