Medical Device CE Marking

We are into Product & QMS Regulatory Consulting for Drugs, Medical Device & Food

MedDeviceCorp provides United States FDA and European Regulatory Compliance Consulting for product and Quality Management System. Our services are aimed for Medical Device CE Marking, FDA 510k, FDA Registration for Medical Device, Drugs, Food, Cosmetics & Nutraceuticals. MedDeviceCorp services are designed to help customer Online by developing submission documents via Cloud server. Our consultants move to client location rarely for solving critical issues, thereby reducing the cost. Our services are often comes with service assurance or guarantee. We have associates and consultants spread across various countries across the Globe.

Read More

OUR SERVICES

YOUR FIRST-HAND SOLUTIONS TO EU AND US REGULATIONS

MedDeviceCorp is a leading Quality Assurance and Regulatory consulting provider to healthcare industries all over the world to comply with European and USFDA requirements. Our far-reaching services are created to support you to achieve and keep-up with regulatory success. MedDeviceCorp facilitates the entry of quality products in the European and the USA markets by offering quality services to our clients around the world.

Our network of management and pharma consultants, testing laboratories, full- time technical consultants, multiple office locations in different continents and well-wishers from 3600 + satisfied customers make us one of the most reputed and trusted service providers delivering economic, quality, timebound solutions for the customers around the globe.

Our services include:

CE Marking of Medical Devices

CE Marking of medical devices signifies that the medical device is in conformity with health, safety, and environmental protection standards and sold within 28 EU Member countries, EFTA/EEA countries covering Norway, Liechtenstein, Iceland, Turkey & Switzerland.

MedDeviceCorp consultants provide following services to the medical device firms for attaining the CE marking:

  • Technical File Preparation-We provide structured solutions for developing high quality Technical File for any risk class, starting from drafting of the File, reviewing and modifying the contents, support in analyzing and filling the Gaps, submissions to the Notified Body of your choice and also coordinate with Notified Bodies till documentation is approved.
  • Notified Body Submission and Coordination till Certification
  • Testing
  • Clinical Evaluation - Our specialist writers will simplify and well-organize the Clinical Evaluation Report for early stage NB approval or to safeguard CE Certificate Validity.
  • PMS and PMCF
  • Risk Analysis

(EN) ISO 13485:2016 Implementation

Medical device manufacturers, finished goods manufacturers, medical software developers, medical device designers and developers and pharmaceutical suppliers interested in enjoying worldwide presence must prove that their medical devices are manufactured under certain auditable standards, which means it is safe and effective. ISO 13485:2016 Certification is a solution for this issue!

MedDeviceCorp consultants provide following services to the medical device firms for attaining the ISO 13485:2016 certification:

  • Consulting
  • Gap Analysis
  • Training
  • Internal Audit

USFDA 510(k) Preparation

If you are planning to market your medical device in the USA and, if your device is substantially equivalent to the medical device already in the market, then the FDA 510(k) path is likely the way to go. It is the fastest and most cost-effective way to get your medical device cleared.

MedDeviceCorp consultants provide following services to the medical device firms for the USFDA 510(k) preparation:

  • Medical Device Establishment Registration
  • Device Listing
  • 510(k) Preparation
  • Guidance
  • FDA Submission and Communication
  • US Agent

21 CFR 820 & MDSAP

FDA 21 CFR Part 820, also known as the Quality System Regulation [QSR] which explains the Current Good Manufacturing Practice [CGMP] regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished medical devices intended for human use and sale in the United States Of America.

On the other hand, the Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer's QMS which satisfies the requirements of multiple regulatory jurisdictions.

MedDeviceCorp consultants provide the following services to the medical device firms for the 21 CFR 820 & MDSAP:

  • Perform GAP analysis in line with ISO 13485:2016 and the quality and regulatory requirements of Australia, Brazil, Canada, Japan & US.
  • Verify procedures, process, documentation, supporting objective evidence that the system is effective
  • Evaluate control over critical suppliers and review adverse event reporting / recall / advisory notice information per country
  • Prepare a written audit report of our findings
  • Training
  • Gap Analysis
  • FDA 483 Response

MedDeviceCorp team of Medical Device Consultants are highly qualified and experienced in medical device regulatory and quality assurance. We have a pool of more than 36 consultants, Medical Writers, Lead Auditors in Germany, India & USA and, have faced more than 3000 product compliance and system/GMP compliance covering multiple risk categories from multiple countries.

Why MedDeviceCorp?

  • Turnkey regulatory solutions
  • Dedicated and resultant-orient services
  • Professionalism
  • Worldwide operations and associates
  • Online and Offline services
  • User-friendly web platforms, assures monitoring of activities online
  • Work completion with results in shortest time
  • Very economic

At MedDeviceCorp, we have solutions to every problem and expertise to meet the regulatory hurdle that you face pertained to the EU and US FDA.