Accumed Sagl
Accumed Sagl offers MedTech regulatory and business consulting, specializing in Swiss Authorized Representative, EU Authorized Representative, and UK Responsible Person services.
About
**Who they are**
Accumed Sagl is a MedTech consulting firm specializing in regulatory and business development services. They focus on providing essential representation for medical device manufacturers in key markets.
**Expertise & scope**
* Swiss Authorized Representative (CH-REP) services
* EU Authorized Representative (EU-REP) services
* UK Responsible Person (UKRP) services
* MedTech regulatory consulting
* Business development consulting
**Reputation / proof points**
* Based in Switzerland, serving the CH market.
* Operates in the MedTech industry.
Accumed Sagl is a MedTech consulting firm specializing in regulatory and business development services. They focus on providing essential representation for medical device manufacturers in key markets.
**Expertise & scope**
* Swiss Authorized Representative (CH-REP) services
* EU Authorized Representative (EU-REP) services
* UK Responsible Person (UKRP) services
* MedTech regulatory consulting
* Business development consulting
**Reputation / proof points**
* Based in Switzerland, serving the CH market.
* Operates in the MedTech industry.
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
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Specializes in Swiss Authorized Representative (CH-REP) services.
Source
“specializing in Swiss Authorized Representative (CH-REP), EU Authorized Representative (EU-REP), and UK Responsible Person (UKRP) services.”
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Offers EU Authorized Representative (EU-REP) and UK Responsible Person (UKRP) services.
Source
“specializing in Swiss Authorized Representative (CH-REP), EU Authorized Representative (EU-REP), and UK Responsible Person (UKRP) services.”
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Provides MedTech regulatory and business consulting.
Source
“Accumed Sagl offers MedTech regulatory and business consulting, specializing in Swiss Authorized Representative (CH-REP), EU Authorized Representative (EU-REP), and UK Responsible Person (UKRP) services.”
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
Languages:
English, Italian, Spanish.
Timezones:
CET
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
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