Passarini Blog
Annual adjustment of FDA medical devices fee rates
September 30 of each year ends FDA Fiscal Year or FY. As a result of this change, there is an adjustment in the FDA fee rates. For the FY 2020, the standard and small business values increased by 6% when compared to the fee rates [...]
ISO 13485: 2016 and its relationship with Computer Systems Validation
ISO 13485: 2016 and its relationship with Computer Systems Validation The newest edition of ISO 13485 was a new approach on the validation of productive processes using computer systems. They are covered by this new approach from high level language software like as ERPs, production [...]
Consulting in Clinical Research
Consulting in Clinical Research In order to offer a complete solution to our customers, Passarni Regulatory Affairs has established a partnership in the clinical research market with GRINN. GRINN is a contract research organization (CRO) specialized in innovative study designs for Clinical Trials, Literature Reviews and Real [...]
What is GMP?
What is GMP? GMP refers to the Good Manufacturing Practices Regulations defined by the Health Regulation and Health Surveillance Agencies of several countries. These regulations, which have the force of law, require manufacturers, processors and distributors of medicines, cosmetics, medical devices and food products to [...]
Systems Validation
Systems Validation With the great supply of management software available along with the relatively low cost of deployment, many medical companies started to control everything via system, eliminating much of the printed documentation, bringing great benefits in the management of the company. The counterpoint to [...]
Hospitalar Fair 2019
Hospitalar Fairs 2019 CONFIRMED PRESENCE! Passarini Regulatory Affairs confirms its presence as an exhibitor at the 26th edition of the Hospitalar fair, which will take place from May 21 to 24, at Expo Center Norte in São Paulo / SP. During the event you can [...]
