Accumed Sagl
Verified
Accumed Sagl offers MedTech regulatory and business consulting, specializing in Swiss Authorized Representative, EU Authorized Representative, and UK Responsible Person services.
About
Accumed is a Swiss based consultancy company founded by specialists with 30+ years of experience in the healthcare field, providing strategic support and specialized services to empower start-ups and SMEs in scaling their businesses.<br><br>Our services:<br>REGULATORY<br>Provide strategic regulatory consulting for medical devices across Switzerland, the European Union, and the United Kingdom.<br><br>BUSINESS DEVELOPMENT<br>Set up and manage international sales networks for medical devices, supporting SMEs and start-ups in market expansion.
Additional information
Accumed Sagl assists medical device manufacturers in navigating complex regulatory landscapes. Their services are crucial for companies seeking to place their products on the Swiss, EU, and UK markets. By acting as the local representative, they ensure compliance with regional requirements, facilitating market access and ongoing regulatory adherence. This includes managing communication with authorities and ensuring post-market surveillance obligations are met.
Key Highlights
- Specializes in Swiss Authorized Representative (CH-REP) services.
- Offers EU Authorized Representative (EU-REP) and UK Responsible Person (UKRP) services.
- Provides MedTech regulatory and business consulting.
Certifications & Trust Signals
- Trusted Partner in MedTech Consulting
Buyer Snapshot
Best for
- Medical device manufacturers targeting the Swiss market
- Companies needing a CH-REP
How engagement typically works
- Consulting partnership
- Regulatory representation
Typical deliverables
- CH-REP services
- Regulatory strategy support
- Business development guidance
Good to know
- Best when requiring a Swiss Authorized Representative for MedTech products.
HQ:
Morbio inferiore, CH
Website:
accumed.eu
Public email:
info@accumed.eu
Languages:
English, Italian, Spanish.
Timezones:
CET
Access:
Verified
Claim status:
Claimed
Services & Capabilities
Find CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical Devices, IVD
Portfolio:
6-25
Flags:
implantable, sterile, measuring, class_iii, ivd, fast_onboarding, multi_language_support, multi_country_coverage
Response SLA:
48 hours
Onboarding time:
3–7 days
Pricing model:
Custom pricing
Starting from:
CHF 3,000
Included services:
Mandate agreement and registration with Swissmedic, Technical documentation review and maintenance, Vigilance and incident reporting support, Post-market surveillance coordination, Labeling and language compliance support, Liaison with competent authorities, Complaint and field safety notice record keeping
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
Swiss Local Contact:
Yes
Labeling Support:
Yes
Swiss Entity Canton Or Region:
Ticino
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
eu_ar
Jurisdictions:
EU
Countries:
Spain, Italy, France, Germany, Netherlands, Austria, Belgium, Denmark, Sweden, Ireland, Portugal, Czech Republic, Greece, Romania, Poland, Norway, Finland
Industries:
Medical Devices, IVD
Portfolio:
6-25
Response SLA:
48 hours
Onboarding time:
3–5 days
Pricing model:
Custom pricing
Starting from:
EUR 2,500
Included services:
Label review, Vigilance, EUDAMED registration, UDI support
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, Class IIb, Class III, Class Is/Im/Ir, Class IIa, IVD
Post Market Support:
Yes
Labeling Review:
Yes
Can Be Named On Label:
No
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
⚡ Instant booking available
Appoint a Swiss Authorized Representative (CH-REP) for Medical Devices
Compare Accumed Sagl and other vetted providers — instant pricing, no RFQ needed.
