Quality: The Cornerstone of Everything We Do
We emphasize the importance of product quality and process execution in our efforts to deliver products that meet our internal standards and customer expectations. We focus on implementing stringent processes and maintaining a robust quality and regulatory management system as part of our comprehensive approach to product development and delivery. You need a culture where commitment to adherence and operational excellence lies at the foundation of every step, with team members who take a proactive approach to mitigating risks before they become problems.
Our dedication to quality and regulatory standards supports our efforts to enhance efficiency and effectiveness throughout our operations—from design and development to manufacturing and post-launch activities.
Key Aspects of Our Approach Include:
- Implementing standardized global quality system processes, tools and software platforms
- Adopting a proactive approach to risk management
- Upholding stringent processes and fostering a quality-focused culture
- Integrating robust quality controls embedded into product designs from the start
- Regulatory compliance across all sites to comply with applicable legal, industry and country-specific standards
One QMS. One Quality Culture.
The words “quality” and “regulatory” are synonymous with medical, pharmaceutical and diagnostic device design, development and manufacturing. In addition to certifications, accreditations and registrations, Phillips Medisize leverages one Quality Management System (QMS) across all 23 production facilities in North America, Europe and Asia; and, of equal importance, quality is deeply embedded in our vision, values, culture, products and solutions.
One Quality Management System synchronized across all global locations
- Shared Quality manual, values and vision
- Standardized SOPs, work instructions, templates and forms
- Consistent, customer-facing documentation
- Uses SAP (global ERP system) as the backbone for the Quality Management System
- One global Approved Supplier List
- Standardized quality metrics and corporate oversight
To learn more about our quality journey, read Building a Quality Culture to Improve Healthcare Manufacturing, by Cheryl Norder, Vice President, Quality & Regulatory.
Regulatory Capabilities to Support Your Needs
Effectively navigating the complex regulatory requirements for medical devices, pharmaceuticals and combination products is essential for a successful development program. Our team of in-house regulatory experts have an established record of success and provide a comprehensive range of regulatory services. We define critical regulatory pathways and objectives to support planning for the market introduction of your new products, while also assisting with end-of-life processes
Specifically, the Team Can Help With the Following:
- Streamlining product development and compliance needs using regulatory strategy services tailored to the biotech, pharmaceutical and medical device sectors
- Providing legal manufacturing services, including managing Drug and Device Master Files for clients and maintaining device registrations such as the Master Access File (MAF)
- Supporting compilation of Device Technical Files and liaising with notified bodies
- Utilizing extensive experience with regulatory agency interactions (FDA, EMA, MHRA) and authoring regulatory submission documents, including responding to regulatory requests for information during the review process
- Developing global, regional and local regulatory strategies and providing submission expertise for new chemical entities and generics
- Offering Chemistry, Manufacturing and Controls (CMC) services to enhance manufacturing and quality control compliance, which supports smooth regulatory approvals
- Ensuring regulatory compliance and market success with expert labeling services designed for clear communication and compliance
- Providing pharmacovigilance and device vigilance capabilities, including appropriate reporting to competent authorities in both the development and post-marketing phases across geographies
Committed to Compliance
Phillips Medisize’s Quality Management System (QMS) adheres to various standards and regulatory requirements, aligned with the products and countries in which we operate or distribute. Our QMS is designed with flexibility to meet both customer needs and regulatory demands.
The QMS is appropriately certified or registered by location and includes the following:
- 21 CFR 820 FDA Quality System Regulation
- 21 CFR 210/211 Current Good Manufacturing Practice for Finished Pharmaceuticals
- MDSAP — The Medical Device Single Audit Program
- MHRA-MIA (IMP) Manufacturing Authorization for Investigational Medicinal Products
- MHRA GMP License per UK Medicines for Human Use Clinical Trial Regulations 2004 [SI2004/1031]
- (EU) 2017/745 Medical Device Regulation
- ISO 13485 Medical Devices
- ISO 9001Quality Management Systems
- IATF 16949 International Automotive Task Force
Additionally, the QMS complies with the following regulations:
- FDA 21 CFR, Part 803 — Medical Device Reporting
- FDA 21 CFR Part 830 — Unique Device Identification
- FDA 21 CFR, Part 4 — Regulation of Combination Products
- FDA 21 CFR Part 801 — Labeling
- FDA 21 CFR, Chapter IX — Tobacco Products
- Directive 2001/83/EC — Community Code Relating to Medicinal Products for Human Use
- Commission Directive 2003/94/EC — Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for Human Use
- ISO 14971 — Risk Management for Medical Devices
- Medical Device Directive 93/42/EEC
- Japan Quality Management System Compliance (MHLW Ordinance No. 169)
- Australia Therapeutic Goods (Medical Devices) Regulations 2002: Schedule 3, Part 1 — Full Quality Assurance System
- National Medical Products Administration (NMPA) — Quality Management Systems
- Canadian Medical Devices Regulations (SOR/98-282)
- Korea MFDS Medical Device Registration
- Brazilian Health Regulatory Agency (ANVISA)
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