Medical Device Consultancy provides specialist business development and regulatory affairs consultancy to medical device, in-vitro diagnostic and related companies, including partner search and selection projects.
Medical Device Consultancy (MDC) works with experienced specialist consultants in Europe, North America and beyond to provide in-depth assistance with:
- Strategic business reviews & planning, marketing, research and product management from concept to market.
- Partner search and selection, including mergers and acquistions.
- Preparation for FDA inspections or Notified Body audits, including mock inspections / audits.
- Regulatory documentation to comply with European Union Directives or FDA requirements.
- European Authorized Representative services and US Agent capability.
- Pragmatic quality management system development for starts-up through to multinationals that meet the international requirements of US FDA Quality System (QS) Regulation / Medical Device Good Manufacturing Practices (GMP); ISO 9001: 2008 and ISO 13485: 2003 Medical devices – Quality management systems – Requirements for regulatory purposes.
- Validation procedures for processes, products and software.
- Specialist executive mentoring and personal development.
- We believe in skills and knowledge transfer, not a dependency culture.
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We have extensive experience of:
- All aspects of business development, especially strategy, strategic market research, marketing, planning and return on investment analysis.
- Finding appropriate partners, especially in the UK, United States and Europe.
- Strategic marketing review of medical devices and diagnostics.
- Providing assistance in all aspects of product management from concept to market.
- Preparing documentation to meet US and European regulatory requirements such as Technical Files, 510(k)s, Premarket Approvals (PMAs) and Clinical Evaluation.
- Introducing and improving quality systems to satisfy US and European regulators.
- Preparing for European Notified Body and US Food and Drug Administration (FDA) regulatory audits / inspections.