Quality and Approval as a Medical Device

As a manufacturer of medical devices, we are very familiar with the boundary conditions for approval of medical devices. So that you can fully concentrate on your core expertise, we will stand by you as a competent partner for all approval matters. We support you in marketing your product and prepare it for approval for national and international markets. On several occasions, we have approved products to 510 (k) standards for the US market.

Our services:
  • Advice for approval related issues in product development

  • Standards and patent research

  • Compilation of technical documentation and review of existing documents

  • Support in the areas of risk management (DIN EN ISO 14971), software development process (ISO 62304) and serviceability (DIN EN ISO 62366)

  • Creation of accompanying documents

  • Communication with test laboratories and Notified Bodies

  • Verification of compliance with the essential requirements of the MDD

  • Creation of applications for approval

Quality Assurance & Regulatory Affairs
Verification
and Validation

Software & Hardware

Verification

Test Automation

Regulatory
Affairs Consulting

Premarket Submission

510(k), MDD

IEC60601-2-4, 2-25

Reviews

HIPAA & Cybersecurity

Compliance

Quality Consulting

Quality Management System

(FDA QSR/ISO 13485)

Risk Management

(Iso 14971)

Audits and

Assessment Services

Manufacturing Process Validation

Process-Identification

for Validation

Production

Process FMEA

Validation:

IQ, OQ & PQ

Regular Control

and Revalidation

Quality Certificates:

Process Software

Validation

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