heretofore Mika Reinikainen, LL.M., MBA is the founder and Managing Director of AbNovo Ltd. In the first 12 years of his career, Mr Reinikainen was in charge of European Corporate Regulatory Affairs for Pfizer Hospital Products dealing with a variety of products of the company’s subsidiaries such as orthopaedic implants (Howmedica), cardiovascular implants and devices (Shiley), …
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AbNovo’s unique one stop shop service provides a single gateway to key service providers spanning full product and business life cycles. Among these are: Product design and development Full CE marking in Europe and UKCA marking in the UK US marketing clearance (PMAs and 510(k)s) Quality assurance systems (setting up and auditing) Clinical trials and …
Our unique partnership approach to providing services as a UK Responsible Person means that we: first get to know your products and business objectives stay in touch: we don’t just collect invoices, we talk to you actively are pro-active: we look out for warning signs in the regulatory environment and keep you informed strive to …
AbNovo’s own staff will provide high level strategic consulting and legal-regulatory interpretation. These services include: General regulatory strategy and advice (all compliance issues) Due diligence audits Briefing on current regulatory trends Legal and regulatory interpretation (including European and national requirements within the European Union as well as the United Kingdom) Post-market surveillance (including vigilance) Enforcement …
AbNo√o … for new beginnings Mika Reinikainen, who has over 40 years of experience in European medical device affairs, founded AbNovo Ltd in 2007. The company became operational in the spring of 2008. AbNovo Ltd provides network based comprehensive outsourcing solutions for manufacturers of medical devices. We have an unparalleled network of highly qualified service …
AbNovo Ltd is a regulatory consultancy focusing on requirements for medical devices in the European Union and the United Kingdom Our one stop shop approach, using network partners, enables us to resolve problems arising throughout product and business life cycles. Abnovo can also act as a UK Responsible Person for non-British manufacturers as well as …