We help medical device manufacturers and start-ups to improve safety of medical devices. We work continuously with them throughout the complete product life cycle. Our main focus is design assurance and compliance with the applicable regulations and quality management systems such as;
✅EU MDR 2017/745
✅EU MDR 2017/746
✅US FDA 510 (K) Submission
✅ ISO 13485 including MDSAP scheme
✅ISO 14971 Risk Management
With the latest revisions, the medical device regulations such as MDR, IVDR have been more complex than ever for medical device start-ups. All regulators within the developed countries are trying to increase the safety of medical devices within their market Therefore, patient safety and compliance to regulatory requirements constitute the basis of our consultancy project objectives. Our customer-focused team provides effective and fast services for each type of project and medical device.
To help our customers in this complicated journey, we use our wide knowledge and experience to simplify the process. By doing this we always consider the balance between commercial needs and regulatory compliance. Our team with Notified Body experience is competent in risk management technical, regulatory, quality, and clinical requirements will provide you tailored solutions.
This approach will speed up your certification process, whether you are a small start-up company or a competent medical devices manufacturer which aims to put new devices on the medical device market.
Do not hesitate to contact us via askto@medloft.net or through https://medloft.net/contact-us/
We will analyse your needs and provide an effective, fast and reliable roadmap.
Company Details
- Employees
- 3
- Founded
- -
- Address
- Podgorica, Podgorica 81000 , Me
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- https://medloft.net/
- Keywords
- Medical Device, Medical Device Quality Assurance, Regulatory Compliance, MDR (EU 2017/745), IVDR (EU 2017/746), 93/42/EEC, ISO 13485:2016, Medical Device Clinical Evaluation, PSUR (Periodic Safety Update Report), Person Responsible for Regulatory Compliance, Technical File Preparation, Risk Management, PMS (Post Market Surveillance), Gap Analyses, Audit, In House Training, FDA 510 K, Medical Device Software Validation.
- HQ
- Podgorica, Podgorica
Medloft Consultancy Doo Questions
Medloft Consultancy Doo's website is https://medloft.net/
Medloft Consultancy Doo's LinkedIn profile is https://me.linkedin.com/company/medloft-consultancy
Medloft Consultancy Doo has
3 employees.
View email and phone details for 3
employees at Medloft Consultancy Doo.
Medloft Consultancy Doo's industry is
Business Consulting and Services
Medloft Consultancy Doo's top competitors are
Rigicon® Innovative Urological Solutions,
Sgs,
Medloft | Primary Health Center Margareten,
Hodjatech,
Epsilon Radioactive Sources (Ers),
Sağlık Forumu,
Soavian Yazılım Ve Teknoloji Çözümleri,
Medloft Teknoloji Ltd (Consulteam Medical),
Fisher & Paykel Healthcare,
Gazi Endüstri A.ş.
Medloft Consultancy Doo's categories are Business Consulting and Services
Medloft Consultancy Doo's founding year is 2018
