Medtechbyrån
MedtechByrån is an expert company in regulatory compliance and quality management, helping clients achieve market approval for medical devices and pharmaceuticals. Founded in 2014, they offer tailored solutions to meet the needs of their clients' products and operations, with a focus on making life science available.
Industries
Nr. of Employees
small (1-50)
Medtechbyrån
Linköping, Ostergotlands Lan, Sweden, Europe
Products
Regulatory Consulting for New Product Launch
Medtechbyrån assists companies in understanding regulatory requirements for launching new medical devices or pharmaceuticals, helping them achieve market approval efficiently.
Regulatory Consulting for New Product Launch
Medtechbyrån assists companies in understanding regulatory requirements for launching new medical devices or pharmaceuticals, helping them achieve market approval efficiently.
Support for Established Companies
The company provides assistance with transitioning to new regulations like MDR and optimizing specific problem areas for established businesses.
Support for Established Companies
The company provides assistance with transitioning to new regulations like MDR and optimizing specific problem areas for established businesses.
Regulatory Consulting for New Product Launch
Medtechbyrån assists companies in understanding regulatory requirements for launching new medical devices or pharmaceuticals, helping them achieve market approval efficiently.
Regulatory Consulting for New Product Launch
Medtechbyrån assists companies in understanding regulatory requirements for launching new medical devices or pharmaceuticals, helping them achieve market approval efficiently.
Support for Established Companies
The company provides assistance with transitioning to new regulations like MDR and optimizing specific problem areas for established businesses.
Support for Established Companies
The company provides assistance with transitioning to new regulations like MDR and optimizing specific problem areas for established businesses.
Services
Product qualification and classification
Assessment of applicable regulatory framework and product classification to define applicable requirements.
Regulatory strategy and market access planning
Develop regulatory strategies to achieve market authorization, including jurisdictional planning for EU and US markets.
GSPR applicability and checklist preparation
Identify which General Safety and Performance Requirements apply and produce a checklist of required activities and documents.
Quality management system implementation and optimisation
Design, implement or improve QMS to align with relevant standards and prepare organisations for certification audits.
Technical documentation preparation
Produce technical files and supporting documentation required for conformity assessment and market approval.
Supplier and vendor auditing
Conduct internal and external supplier audits and provide training in audit management.
Product qualification and classification
Assessment of applicable regulatory framework and product classification to define applicable requirements.
Regulatory strategy and market access planning
Develop regulatory strategies to achieve market authorization, including jurisdictional planning for EU and US markets.
GSPR applicability and checklist preparation
Identify which General Safety and Performance Requirements apply and produce a checklist of required activities and documents.
Quality management system implementation and optimisation
Design, implement or improve QMS to align with relevant standards and prepare organisations for certification audits.
Technical documentation preparation
Produce technical files and supporting documentation required for conformity assessment and market approval.
Supplier and vendor auditing
Conduct internal and external supplier audits and provide training in audit management.
Expertise Areas
- Regulatory compliance for medical devices and pharmaceuticals
- Quality management systems (QMS) implementation and certification
- Regulatory strategy and market access (EU and US focus)
- Technical documentation for conformity assessment
Key Technologies
- Quality management systems (QMS)
- Technical documentation for regulatory submissions
- GSPR assessment for medical devices
- Supplier and vendor auditing methodologies