Resources
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Medical Device Single Audit Program (MDSAP)
Many of my clients are beginning to investigate whether joining the Medical Device Single Audit Program (MDSAP) is a good fit for their organisation. The program allows an MDSAP recognized Auditing Organization (AO) to conduct a single regulatory audit …
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CE Mark process for a medical device
Many of my interactions with clients begin when they contact me wishing to gain CE Mark approval for their device to allow them to sell the product into the European Economic Area (EEA). We generally begin with high-level training to support their unde …
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Vigilance and Medical Device Reporting
In order to ensure that medical devices distributed to the market remain safe and perform as intended, adverse events or incidents are reported to the appropriate Regulatory Authorities. In Europe, this system is known as the vigilance system. In the U …
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Medical Device Clinical Investigations
Support related to clinical investigation planning and execution for the EU and US markets is a common client request. The first step every medical device organisation must take is to determine whether a clinical investigation (sometimes referred to as …
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Quick Links
- Directive 93/42/EEC regarding medical devices (MDD)
- Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD)
- Directive 90/385/EEC regarding active implantable medical devices (AIMD)
- EU Regulation 2017/745 on Medical Devices
- EU Regulation 2017/746 on In-Vitro Diagnostic Devices
- USA CFR – Code of Federal Regulations Title 21 Part 820
- FDA’s MAUDE – Manufacturer and User Facility Device Experience
- ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
- ISO 14155 Clinical investigation of medical devices for human subjects – Good clinical practice
- ISO 14971 Medical devices – Application of risk management to medical devices
How Can I Help Your Project?
If you are a medical device innovator who demands excellence, then contact Neasa Greene Consulting today for an initial consultation.