Regulatory Requirements change. We keep track, so you don’t have to.
Update Services
Our Update Services run in the background – so you can focus on your product. They can be booked independently, are updated quarterly or semi-annually, and directly integrated into your QM System.
An overview of our update services
Regulations Update Service
From hundreds of regulations to a clear, product-specific overview. We research which standards, guidelines, and regulations are applicable to your product and your QM System – and keep this overview continuously updated in our database.
- Quarterly report with all relevant changes – including direct links to the amended regulations
- Coverage: EU market (CE), USA, UK, Canada, Switzerland, Taiwan, and more
- Directly updated list of applicable regulations – no maintenance effort on your part
- On request: detailed GAP-Analysis with practical recommendations for action
Frequency: Quarterly
Free initial consultationVigilance Update Service
Vigilance requirements are regulated differently worldwide and change continuously. Who must report what, when, and to whom – you as the manufacturer or your local partner? We keep track of everything for you.
- Semiannual monitoring of Vigilance requirements for (Serious) Incidents, Recalls, Field Safety Notices (FSNs), and Field Safety Corrective Actions (FSCAs) in over 70 countries
- Clarification of responsibilities: manufacturer or local partner?
- Semiannual report with regional changes – including amended legal texts
- Directly updated country overview – no maintenance effort, prepared for your Quality Management System
Frequency: Semiannual
Free initial consultationPMS Update Service
PMS requirements are becoming more relevant worldwide – and are regulated just as differently as Vigilance requirements. When must which Periodic Safety Update Report (PSUR) or PMS Report be made available to whom? What deadlines apply? We provide the answers.
- Biannual monitoring of PMS requirements in over 70 countries
- Clarification of reporting obligations, deadlines, and responsibilities
- Biannual report with regional changes – including amended legal texts
- Directly updated country overview – no maintenance effort, prepared for your Quality Management System
Frequency: Semiannual
Free initial consultationQMS Update Service
Regulatory changes are not just identified – we deliver fully updated Standard Operating Procedures and templates that you can directly integrate into your QMS. No research, no text creation – just the finished solution ready for use.
- Quarterly update of changed Standard Operating Procedures and templates – ready for integration into your QMS
- Including Regulatory Monitoring
- Best practices and audit feedback are directly incorporated
Frequency: Quarterly
Available only in conjunction with the QM system from regular services.
Which Update Service suits you?
In a brief conversation, we’ll clarify which Update Services are relevant for your products and your markets.
Free initial consultationOur customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors