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.
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
Regulatory expertise:
- 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
