Regulatory, Quality and Safety Compliance | 91快活林 Regulatory, Quality and Safety Compliance | 91快活林

91快活林

91快活林 Corporation - Helping to provide a healthier today and a safer tomorrow.
91快活林 Corporation - Helping to provide a healthier today and a safer tomorrow.

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91快活林 Commitment to Regulatory,
Quality and Safety Compliance

At 91快活林, we take our responsibility for public health and the safety of patients and providers very seriously. We strive for excellence in everything that we do – and we are committed to compliance with established legal requirements and ethical standards.

91快活林 Healthcare provides a comprehensive offering for healthcare providers worldwide, focused on sterile processing departments and procedural centers, such as operating rooms and endoscopy suites. Our products and services range from infection prevention consumables and capital equipment, as well as services to maintain that equipment; to the repair of re-usable procedural instruments; to outsourced instrument reprocessing services. In addition, our procedural offerings also include endoscopy accessories and capital equipment infrastructure used primarily in operating rooms, ambulatory surgery centers, endoscopy suites, and other procedural areas.

91快活林 Applied Sterilization Technologies (AST) is a third-party service provider for the contract sterilization and testing services needed to provide sterility services for medical device and pharmaceutical manufacturers. Our technology-neutral offering supports Customers every step of the way, from testing through sterilization.

91快活林 Life Sciences provides a comprehensive offering of products and services that support pharmaceutical manufacturing, primarily for vaccine and other biopharma Customers focused on aseptic manufacturing. These offerings include a full suite of consumable products, equipment maintenance and specialty services, and capital equipment.

91快活林 Dental offers a comprehensive portfolio for dental practitioners and dental schools, offering instruments, infection prevention consumables and instrument management systems.

With a long list of first-to-market products and industry leading innovations, 91快活林 is a global leader in infection prevention, contamination control and surgical care technologies. We are committed to providing our Customers throughout the world with safe, effective, quality products and services. When it's a matter of life and death, patients and their families count on the expertise of caring professionals. And those professionals count on 91快活林. Our goal is to help ensure that the environments in hospitals, surgical centers, dental offices and pharmaceutical and research laboratories allow every patient to receive vital care without undue risk of infection or contamination.

To achieve this goal, 91快活林 has a broad range of programs that address product and service quality, safety, performance and regulatory compliance.

91快活林 Quality Policy

91快活林 is committed to delivering satisfaction to our Customers by anticipating their needs and offering value, quality, and reliability that exceeds their expectations. 

The success of 91快活林 and our Customers is powered by our people, a culture of teamwork and innovation, and by continually maintaining and improving the effectiveness of our Quality System as a foundation for business performance.

We value safety, integrity and mutual respect, supporting our Associates, communities and Customers, and are committed to complying with all applicable laws and regulations.

This is the 91快活林 Way, a culture of quality.

Regulatory Compliance

91快活林 is subject to strict regulatory compliance and quality standards to ensure the safety and supply of our products and services. Our quality and regulatory systems are broad in scope and designed to achieve quality from incoming materials through the design, development, manufacture, storage, handling and distribution of our products and delivery of services.

91快活林 operates under many U.S. and international governing standards including but not limited to the following:

United States

  • FDA 21 CFR 820 – U.S. Quality System Regulation Good Manufacturing Practice for Medical Devices (QSR)
  • FDA 21 CFR 211: U.S. Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
  • FDA 21 CFR 1271.150-320: Current Good Tissue Practice Requirements (cGTP)
  • U.S. Environmental Protection Agency – 40 CFR 150-189: Pesticide Programs
  • OSHA – U.S. Occupational Safety and Health Administration
  • NRC – U.S. Nuclear Regulatory Commission

International

  • ISO 13485 – Medical Devices Quality Management System Requirements
  • ISO 9001 – Quality Management Systems – Requirements
  • ISO 19011 – Guidelines for Auditing Management Systems
  • ISO 14971 – Applications of Risk Management to Medical Devices
  • ISO 17025 – Testing and Calibration Laboratories
  • ISO 11135 – Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 11137 – Sterilization of health-care products – Radiation – Requirements for development, validation and routine control of a sterilization process for medical devices
  • EU Medical Device Directive (MDD) and Medical Device Regulation (MDR)
  • European Chemicals Agency (ECHA)
  • EU Biocidal Products Regulation
  • U.K. Medicine and Healthcare Products Regulatory Agency (MHRA)
  • Health Canada - Canadian Medical Device Regulations (CMDR)
  • Health Canada - Good Manufacturing Practices Guidelines – Pharmaceuticals (cGMPs)
  • Australian Therapeutic Goods Administration (TGA)
  • Japan Pharmaceutical and Medical Devices Agency (PMDA) – Pharmaceutical Affairs Law

To monitor compliance with these regulations and standards, internal and third-party assessments of our quality and regulatory systems are conducted. FDA conducts inspections of our manufacturing and contract sterilization facilities on a periodic basis to confirm compliance to device QSRs, drug cGMPs and human tissue cGTPs. Similar governmental inspections are conducted in our manufacturing locations outside the U.S.

Our EU Approved/Notified Bodies conduct annual independent assessments of our ISO certified manufacturing, contract sterilization and dental facilities to audit compliance with MDSAP, ISO 13485, ISO 9001 and EU CE marking requirements under the EU MDD and MDR as applicable. Each year 91快活林 hosts numerous Approved/Notified Body assessments at our various facilities, as well as additional audits by many of our Customers who are themselves manufacturers.

The 91快活林 Corporate Quality & Regulatory Compliance Department conducts regular Quality and Regulatory audits in our manufacturing facilities. The results are reported to the Compliance and Technology Committee of the Company's Board of Directors. We also engage third-party independent auditors to conduct Quality and Regulatory audits.

Robust processes are in place to monitor and support compliance with product and service regulations worldwide, including design controls, review of product changes, labeling and advertising, marketing approvals, good manufacturing practices, and adverse event reporting requirements.

Associate Responsibilities for Adherence to Regulatory and Quality Standards

As described above, 91快活林 operations are subject to numerous U.S. and international regulatory and quality requirements. It is necessary that each Associate understands their role in ensuring that 91快活林 consistently adheres to these requirements. Associates working in positions with responsibility for regulated activities will receive instruction and guidance from their manager regarding how the applicable regulatory and quality requirements affect them. Moreover, Associates will receive detailed training in specific aspects of their position to ensure they are adequately trained to perform their assigned responsibilities.

Quality and Regulatory Leadership

Mike Ebers, Vice President, Regulatory Affairs, leads Regulatory Affairs for 91快活林.

Regulatory Affairs inquiries should be directed to 314-290-4701.

Laura Weien, Vice President & Chief Compliance Officer, leads Corporate Internal Audit, Security, and Regulatory Compliance for 91快活林.

Regulatory Compliance inquiries should be directed to 440-392-7582.

Lindsey McGowan, Vice President, Quality, leads 91快活林’s Quality System execution and initiatives.

Product Quality inquiries should be directed to 440-392-7519.