NSF International Experts in Medical Device Training, Testing, Consulting, Auditing and Regulatory Support
Medical device organisations have been put under the spotlight recently due to public health concerns. The industry is scrutinised by regulators across the globe. NSF International’s (NSF) consulting, testing, auditing and education services address today’s highly complex, high-risk medical products across the entire lifecycle.cycle.
NSF has assembled a specialist team in the regulatory, scientific, analytical testing and compliance field that understands the regulatory and safety requirements needed to bring medical products onto the market – and sustain them.
Medical device auditing services
Global medical device organisations are seen as one of the most audited industries today, subject to internal audits and multiple external audits from a wide range of regulatory agencies. We understand these challenges and the ever-increasing requirements placed on stakeholders in the global medical device market by regulatory, social and economic changes. NSF provides a comprehensive range of auditing services to support you, whatever your place in the market.
Recognising the varying degrees of support an organisation requires during the product lifecycle, NSF offers a range of services to meet your needs both internally and for external compliance, including quality systems requirements, local and international regulations, market and clinician expectations and ever-increasing patient expectations.
Our auditing services include:
- Pre-audits and assessments against global regulations, including EU, US FDA, Japan, China, Canada and Australia
- ‘Health check’ audits, enacting the role of a regulator or notified body to provide a gap analysis of your organisation’s compliance and capability to meet external requirements
- Auditing of design dossiers and technical files for US FDA 510(k), CE mark and other market submissions
- ‘Health check’ audits against best practices in design control, validation, risk management, CAPA, process and supplier control
- Due diligence audits to assist all parties with acquisition decisions
- Auditing of the capability of your supply chain to meet your specifications and requirements
- Auditing and benchmarking of your organisation against QA / regulatory / market requirements
- Auditing of manufacturing and technology-related validations, measurement systems, computer software, cleaning, sterilisation and packaging validations
- Audit of design-related validation projects, pre and post-implementation, testing, scientific and analytical validations
- Full audit solution management and preparation of audit strategies
- Development of your organisation’s internal audit capabilities through training and coaching
Specialist medical device expertise
Our auditors possess specialist knowledge and expertise in all key areas of medical devices. Product competencies include:
- Orthopedic and dental implants and materials
- Microbiology and sterilisation
- IVD reagents and devices
- Ergonomics and usability
- Cardiovascular devices, including implants
- Advanced technology medical products (ATMPs)
- Electromedical devices
- Animal tissues
- Drug / device combinations
- Human blood derivatives
- Active implants, including pacemakers
- Biocompatibility and toxicology
Medical device consulting services
The demands on the medical devices market for applying regulatory science are ever-increasing. You must demonstrate that you have applied the most appropriate science and risk-based solutions, while balancing your budget.
NSF consulting services can help you meet your requirements, whatever your size or technology. Our capabilities include helping you to understand the regulatory landscape of a new market by outlining the regulatory requirements.
NSF specialises in drug / device, device / drug, drug / biologic, device / biologic combinations and in-vitro diagnostic products.
Throughout the product lifecycle, NSF can help you by:
- Assigning technical and scientific experts to prepare regulatory authority briefing papers
- Planning and managing your clinical evaluation strategy
- Outlining your product safety assurance and testing programs
- Recommending and managing your product and process validation strategies
- Working on your behalf with specialist regulatory agencies to determine the most effective product registration methods
- Implementing the most appropriate GMP program for your company and supply chain
- Developing your quality control testing program and product release strategy
- Building and compiling your scientific and technical dossiers
Technological, scientific, regulatory and analytical medical device expertise
The NSF medical device consulting team understands your daily challenges in this industry and the capabilities of our expert team include:
Technological and scientific expertise:
- Technological expertise in borderline and novel devices, including drug / device, device / drug, device / tissue and other complex device classification and product registration requirements.Scientific personnel are able to outline the principle mode of actions of your device and provide independent and impartial scrutiny of regulatory agency opinions
- Clinical personnel with specific clinical experience in medical device combination product evaluation and investigation
- Experts able to prepare pre-clinical scientific briefings to aid in regulatory classification decisions and complete support for testing and clinical evaluation
- Medical device risk management experts covering the entire spectrum of technology, user and clinical risks including toxicology, software, usability and clinical benefit over risk evaluations
- Professional consultants with regulatory agency expertise representing European and US regulatory agencies in the field of compliance and technology
- Regulatory specialists skilled in the compilation, review and submission of scientific evaluation documentation to regulatory agencies at all stages of the regulatory lifecycle (pre-regulatory, pre-market authorisation, conformity assessment review and on-market vigilance systems)
Quality control and analytical expertise:
- Analytical services with the consulting and laboratory resources to appropriately characterise, compare and test a range of chemical and physical entities supporting your safety evaluations
- Quality assurance and engineering expertise
- Quality systems specialists who understand combination product GMP, quality system implementation for worldwide agencies and the differences and similarities between US, EU, Japanese and a range of emerging market quality system requirements
- Validation engineering specialists covering a broad spectrum of mechanical, software, chemical, packaging and sterilisation processes
Products and Services
Compliance and Remediation Services
NSF International provides expert compliance solutions to medical device companies. Its staff of former US Food and Drug Administration (FDA) officials, EU officials, and industry experts combines global regulatory knowledge with industry best practices to help you achieve sustainable and compliant quality systems.
Medical Devices Training
NSF International provides regulatory and quality medical device training courses and professional qualifications. Its courses are highly interactive and based on real scenarios, helping you meet international requirements throughout the product lifecycle.
Quality Engineering and Validation Consulting
Medical device companies require successful implementation of quality engineering and validation to ensure products consistently meet customer and patient needs. NSF's strategic, tactical and technical expertise will help you with programme management, quality assurance (QA), and regulatory compliance.
Quality Management Systems Improvement Consulting
Medical device companies need quality management systems (QMS) that comply with an array of complex and demanding regulatory requirements. NSF has extensive medical device experience in all therapeutic areas including in-vitro diagnostics, lab developed tests, and combination products.
Regulatory Strategy and Market Access Consulting Services
Medical device and in-vitro diagnostic companies of every size and therapeutic area look to NSF's regulatory affairs and market access team to bring innovative healthcare products to market.
How to Respond to FDA Form 483s and Warning Letters
FDA issues hundreds of Form 483s and dozens of warning letters annually. What should you do if one shows up on your desk?
Understanding the Benefits and Purpose of MDSAP
The Medical Device Single Audit Program (MDSAP) was developed in 2012 with the goal of creating a system where a single audit could be trusted across multiple jurisdictions.
Changing the Quality Culture
People are generally happy sticking to what they know, to their tried and tested habits as it is easy and painless.
Microbiological Control of Non-Sterile Products
The microbiology department of a manufacturing facility for non-sterile products can be extremely busy carrying out extensive tests on incoming materials, intermediates, water systems, production equipment, and environmental monitoring.
COPQ in the Pharmaceutical Industry
COPQ is increasingly valuable for the pharmaceutical and medical device industries, where maximising product quality is paramount and defect reduction has an additional knock-on effect.
Deficiencies in QMS
The MHRA has been one of the few regulatory authorities to publish the statistics and classifications for the deficiencies it finds during inspections.
Your Essential Guide to Writing to Regulatory Agencies When Things Go Wrong
Martin Lush gives a guide of exactly what to do when responding in writing to criticism from regulatory agencies.
NSF International has appointed Lynne Byers as executive director and David Waddington as director of its pharmaceutical biotech services in Europe.Read more
NSF has announced the release of a new collection of pharmaceutical workshops for the 2017/2018 period.Read more
NSF’s pharma biotech experts now serving India’s pharmaceutical industry from Gurugram office.Read more
US Food and Drug Administration (FDA) regulations protect the health, safety, and overall quality of products so they do not adversely affect consumers. That is also why current good manufacturing practices (cGMP) are in place.Read more
NSF Health Sciences has announced it will be hosting a two-part webinar to discuss the new label text guidelines for pharmaceticals.Read more
NSF International has announced the launch of its new pharmaceutical biotech app.Read more
NSF’s Global Vice-President Martin Lush to Open 2nd PDA Europe Annual Meeting with Keynote Presentation
NSF International's pharma biotech team has announced it will be present at the 2nd PDA Europe Annual Meeting in Berlin.Read more
Enacted into law December of 2016, the 21st Century Cures Act is an initiative to expedite and enhance the process of discovery, development, and delivery for disease treatments.Read more
NSF International Partner with IDMA to Provide Quality management Courses to Pharmaceutical Industry
NSF International is partnering with the Indian Drug Manufacturers' Association (IDMA) to offer a customised, five-module pharmaceutical quality management (PQM) education programme in Bangalore, India.Read more
NSF International has announced the appointment of a new global vice-president for NSF Pharma Biotech and Medical Devices following Bob Pietrowski's retirement.Read more
NSF International is partnering with non-profit organization Textile Exchange to improve textile industry sustainability.Read more
NSF-GFTC has announced the changing of its name to NSF International.Read more
NSF International has published the first American National Standard for pharmaceutical excipients, NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.Read more
NSF International will be attending the 54th Annual Meeting and ToxExpo from 22-26 March.Read more
NSF International has acquired IPEA, the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas).Read more
NSF International has brought its subsidiary companies together in one Health Sciences Division. NSF Becker & Associates, NSF-DBA and NSF Pharmalytica, as well Dietary Supplement Program, can all now be found in the same place.Read more
NSF International, an independent global public health and safety organization that develops standards, and tests and certifies products for the food, water and health sciences industries, has acquired the INASSA Group of Lima, Peru, which is comprised of three segments: technical analysis, laboratory and sanitation.Read more
NSF Health Sciences has released a free white paper which describes the requirement for a "Qualified Person" (QP) contained in the EU Commission Proposal for a new regulation to cover medical devices and active implantable medical devices.Read more
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