Consultancy in regulatory affairs

Llins's consultants assist manufacturers in their regulatory processes. They will clarify the numerous requirements in the European Directives and Regulations for Medical Devices and In Vitro Diagnostics, propose practical solutions to meet them and/or compose your technical documentation and design dossiers. Whether you only need training in the Directives and Regulations or you want to completely outsource your regulatory affairs activities, Llins can provide a suitable solution. While doing this, we take your ambitions outside Europe into account.

With more than 15 years of experience, Llins's consultants are the perfect support for obtaining the required CE mark, through training, review/composition of technical documentation, assistance in notified body selection and much more. Llins also acts as the European Authorized Representative (EC REP) for In Vitro Diagnostic and Medical Device manufacturers. Our company is the intermediate between the manufacturers and national authorities for a.o. incident management and product notification.

 

Consultancy in quality assurance

Llins’s consultants have successfully assisted IVD and Medical Device manufacturers in achieving ISO 13485 certification and CE certification in more than 100 customer

Llins’s consultants have successfully assisted IVD and Medical Device manufacturers in achieving ISO 13485 certification and CE certification in more than 15 countries on four continents. Depending on the situation, Llins can build the quality system from scratch or only propose essential adjustments to an existing system. We can provide training, perform a quality system gap analysis, give ad hoc advice or manage your quality system on a permanent basis.

The consultants can help IVD and MD manufacturers in the implementation of a Quality System following standards ISO 9001, ISO 13485, 21 CFR 820 and MDSAP.