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Recent activities

Advice on various regulatory issues to a manufacturer of cochlear implant.
Advice to a manufacturer of a cardiovascular implant after a total recall of the product in one EU Member State  and successful negotiations with the National Competent Authority to accept the re-launch of the product.
Review of and corrections to the bilingual Instructions for Use for a cardiovascular implant.
Regulatory risk analysis of potential threats of various national Competent Authorities concerning a drug/device combination product.
Strategic advice and hands on assistance to a manufacturer of a drug/device combination product to deal with queries and potential threats from a National Competent Authority and a Notified Body pressured by the NCA.  Input provided significantly contributed to a successful outcome.
Critical analysis of the regulatory content of a software product intended to assist manufacturers’ compliance with European law.
Investigation of possible national variations (16 countries) in compliance requirements concerning a biological central nervous system implant.
Investigation into potential restrictions in European and national law (5 countries) concerning the use of a specific term in naming medical devices.
Regulatory risk analysis relating to potential action by a National Competent Authority concerning a CE marked implant on the market that may have been wrongly classified.
Advice on Latvian language requirements
Report on medical device product registration requirements in all EU member states.
Investigation on the development of a specific monograph in the European Pharmacopoeia.
Advice and plan of action relating to reregistering medical devices after a major company restructuring.
Review of technical documentation relating to a bare metal stent and a drug eluting stent (with a network partner).
Negotiating with a national Competent Authority to accept a product as a medical device instead of a drug-device combination product.
Assessing regulatory implications of an Internet mediated customer survey.
Advising a manufacturer of a cardiac implant on regulatory and strategic aspects of initiating a European clinical trial.
Advising a manufacturer of a drug/device combination product on how to respond to a Notified Body’s challenge of the accuracy of a test method.
Research into the regulatory implications of leading edge neural implants and neural control of external devices.

Investigation, advice and/or assistance has been provided on the following topics and situations:

National differences in  adverse event reporting during clinical investigation.

Regulatory issues related to cochlear implants.

Successful negotiations with the National Competent Authority to accept the re-launch of a cardiovascular implant after its total recall.

Review of and corrections to the bilingual Instructions for Use for a cardiovascular implant.

Regulatory risk analysis of potential threats of various national Competent Authorities concerning a drug/device combination product.

Dealing with queries and potential threats from a National Competent Authority and a Notified Body relating to a drug/device combination product.  Input provided significantly contributed to a successful outcome.

Critical analysis of the regulatory content of a software product intended to assist manufacturers’ compliance with European law.

Investigation of possible national variations (16 countries) in compliance requirements concerning a biological central nervous system implant.

Investigation into potential restrictions in European and national law (5 countries) concerning the use of a specific term in naming medical devices.

Regulatory risk analysis relating to potential action by a National Competent Authority concerning a CE marked implant on the market that may have been wrongly classified.

Advice on national language requirements

Report on medical device product registration requirements in all EU member states.

Investigation on the development of a specific monograph in the European Pharmacopoeia.

Advice and plan of action relating to reregistering medical devices after a major company restructuring.

Review of technical documentation relating to a bare metal stent and a drug eluting stent (with a network partner).

Negotiating with a national Competent Authority to accept a product as a medical device instead of a drug-device combination product.

Assessing regulatory implications of an Internet mediated customer survey.

Advising a manufacturer of a cardiac implant on regulatory and strategic aspects of initiating a European clinical trial.

Advising a manufacturer of a drug/device combination product on how to respond to a Notified Body’s challenge of the accuracy of a test method.

Research into the regulatory implications of leading edge neural implants and neural control of external devices.

Convincing a Competent Authority to reverse their opinion and to accept that a substance in a medical device has no medicinal mode of action.

Advice on how to transfer the operations of an authorised representative from one EU member state to another.

Advice on the drug agency consultation process in the event of  a change in the drug substance of a combination device.

Advocacy projects to obtain changes in European law and regulatory guidance.

Organised workshops for manufacturers on general regulatory compliance, achieving compliance with new requirements and drug/device combinations.