NSF Health Sciences Experts in Medical Device Training, Testing, Consulting, Auditing and Regulatory Support
Medical device organizations have been put under the spotlight recently due to public health concerns. The industry is scrutinized by regulators across the globe. NSF’s consulting, testing, auditing and education services address today’s highly complex, high-risk medical products across the entire lifecycle.
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 organizations 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.
Recognizing the varying degrees of support an organization 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 organization’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 organization against QA / regulatory / market requirements
- Auditing of manufacturing and technology-related validations, measurement systems, computer software, cleaning, sterilization 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 organization’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 sterilization
- 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 specializes 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 authorization, conformity assessment review and on-market vigilance systems)
Quality control and analytical expertise:
- Analytical services with the consulting and laboratory resources to appropriately characterize, 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 sterilization 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.
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.
Are You Facing a Complexity Crisis?
In this whitepaper, Martin Lush discusses the issue of over-complexity in the pharmaceutical industry.
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.
FDA Issues Draft Guidances With New Regulatory Pathway Options for PMA Products
In April 2014, the FDA released draft guidance documents for premarket approval, Balancing Premarket and Post-market Data Collection for Devices Subject to Premarket Approval (PMA) and Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.
New EU Medical Device Regulation Adopted
This year has brought significant changes to the regulatory landscape across Europe, following the publication of the new European medical device regulation (MDR) and in-vitro diagnostics regulation (IVDR).
EU Medical Device Regulations: Are You Ready for the Impact?
Establishing in-vitro diagnostic products and medical devices in Europe may mean making changes to your business beyond comprehension of new regulatory requirements.
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.
Five Key Processes for GMP Deviation Investigation
When things go wrong, there are five non-negotiable processes that should be defined on your deviation investigation standards of practice (SOP): immediate engagement, gemba, triaging using a documented risk assessment, using the Klein process to determine potential root causes, and documenting in real time using an investigation worksheet.
Total Product Lifecycle Solutions for the Medical and In Vitro Diagnostics Industry
NSF Health Sciences Medical Devices team are recognised as training-experts for regulatory and quality, as well as for consultancy and auditing.
Top Five Myths of Deviation and CAPA Systems
'How to Simplify for Improve your Deviation and CAPA Systems' is one of NSF's most popular in-house courses. The company provides simple tools and techniques that dramatically improve efficiency, while also dispelling some myths. Here is a sample of some of the common myths.
Preparing for Unannounced Inspections from Notified Bodies
Vice-president of Europe-health sciences medical devices at NSF International has offered advice on how to prepare for unannounced audits by notified bodies after Europe introduces further measures.
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 acquired PROSYSTEM, a German medical device consulting firm specialising in regulatory affairs and clinical evaluation.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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