Guides

Straight answers to the questions buyers ask.

What regulatory software a device company needs, how representatives keep mandates in order, and how to track registrations across markets, including when SMEDTEC OS is not the right tool.

Guide · ManufacturersWhat regulatory software does a small medical device company need?An eQMS runs the quality system; regulatory operations software runs market access. What each does, when spreadsheets are still enough, and where SMEDTEC OS fits for small RA/QA teams.
Guide · ComparisoneQMS or regulatory operations software: what's the difference?An eQMS and regulatory operations software solve different problems for medical device companies. A side-by-side comparison of what each holds, who uses it and when you need both.
Guide · RepresentativesHow do EU Authorised Representatives and UK Responsible Persons keep track of their mandates?What a representation mandate carries, why it breaks in spreadsheets once you hold several clients, and how rep firms keep obligations, identifiers, deadlines and evidence per client.
Guide · UK Responsible PersonHow do UK Responsible Person firms keep track of their obligations?What a UK Responsible Person is answerable for across several overseas manufacturers, where the obligations hide, and how UK RP firms keep duties, MHRA registrations, dates and evidence per client.
Guide · RegistrationsHow do you track medical device registrations across the EU, UK, US, Canada and Australia?Who holds a medical device registration in each major market, the identifier to record, and the recurring date to diary, with a practical way to keep them in one place.
Guide · ConsultanciesWhat software do medical device regulatory consultancies use to run client work?How medical device regulatory consultancies run enquiries, engagements, deliverables, knowledge and a freelance consultant network, and what changes when they run it on one platform.