At Specculo, we provide efficient, high-quality regulatory affairs and quality assurance services to medical device manufacturers, importers, and distributors operating in the EU and UK. Our goal is to make compliance straightforward, so you can focus on developing safe, effective products.
๐๐ฎ๐ซ ๐๐๐ซ๐ฏ๐ข๐๐๐ฌ
๐ถ Representation
- EU Authorised Representative (EC-REP).
- UK Responsible Person (UK RP).
We act as your official representative, ensuring that your regulatory responsibilities in the EU and UK are fully met.
๐ถ Regulatory Affairs Consulting
- Technical documentation and gap assessments.
- Device classification and qualification.
- Regulatory strategy and submissions.
- EUDAMED registration support.
- Training services.
๐ถ Quality Assurance Consulting
- QMS implementation and maintenance (ISO 13485:2016).
- Internal and supplier audits.
Whether you are entering the EU or UK market, or strengthening ongoing compliance, Specculo offers clear, practical support at every stage.
Company Details
- Employees
- 2
- Founded
- 2022
- Address
- Balzan, Mt
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- https://specculo.com/
- Keywords
- medical devices, IVDs, EU Medical Device Regulation, EU IVD Regulations, UK Medical Device Regulation, ISO 13485:2016, QMS, Eudamed, Registrations, Training, MDRP, PRRC.
- HQ
- Balzan
Specculo Questions
Specculo's website is https://specculo.com/
Specculo's LinkedIn profile is https://mt.linkedin.com/company/specculo
Specculo has
2 employees.
View email and phone details for 2
employees at Specculo.
Specculo's industry is
Business Consulting and Services
Specculo's top competitors are
Tsm Services Inc.,
Blue Arrow,
Goex Consulting E.k.,
Qlot Consulting,
Kabod Medical Media,
Duke Consulting Gmbh,
Romeo Life Sciences Consulting,
Medifum Group,
Qra Medical,
Sit-Con Gmbh.
Specculo's categories are Business Consulting and Services
Specculo's founding year is 2022
