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We are Global Regulatory and Quality Consulting services for Medical Device industry.

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We offer Regulatory and Quality Management System (QMS) consulting services. Our approach is to design, implement and maintain custom-made integrated QMS models in compliance with the local and essential global regulations.

MDV-Solve

 

In God We Trust, All Others must provide evidence

Our Services

We in MDV-Solve offer Regulatory and Quality Management System (QMS) consulting services.

Our approach is to design, implement and maintain custom-made integrated QMS models in compliance with the local and essential global regulations.    

Our service includes creation, update, implementation, and maintenance, verification of effectiveness of the requested sub-systems to build up an integrated QMS, alongside training and auditing.

Our Services

The new EU MEDICAL DEVICE REGULATION (MDR)

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MDSAP PROGRAM

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Quality System under EN ISO 13485, US FDA QSR - GMP

The purpose is to enable you to establish and implement an effective tailored QMS system including GMP (Good Manufacturing  Practice)

requirements

Design Control Under EN ISO 13485  &  21 CFR PART 820

The purpose is to enable you to establish and implement a system for design controls for various classes of medical devices for local market, the U.S. and Europe.

Network Solutions

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Support Consulting

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The new EU MEDICAL DEVICE REGULATION (MDR)

I'm a paragraph. Click here to add your own text and edit me. It’s easy. Just click “Edit Text” or double click me.

Design Control Under EN ISO 13485  &  21 CFR PART 820

The purpose is to enable you to establish and implement a system for design controls for various classes of medical devices for local market, the U.S. and Europe.

The Literature Route for Clinical Evaluations

This sub-system provide a practical solution on evaluation of clinical data as a necessary part of the European technical file or design dossier for CE marking medical devices and local regulation

The new EU IVD REGULATION (IVDR)

The In Vitro Diagnostic Regulation (IVDR) stipulates all requirements in vitro diagnostic medical device manufacturers will have to comply with. This regulation replaces the existing Directive 98/79/EC.

​The purpose of this training course is to enable you to understand the main points under the new IVDR

MDSAP PROGRAM

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Application of risk management to medical devices

This sub-system is intended to assist medical device manufacturers with the integration of a risk management system into their existing quality management system

Quality System under EN ISO 13485, US FDA QSR - GMP

The purpose is to enable you to establish and implement an effective tailored QMS system including GMP (Good Manufacturing  Practice)

requirements

Process Validation including software

– Test method validation – clean room validation

This sub-system is intended to assist medical device & pharmaceutical manufacturers with implementation of process validation system including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

POST-Market SURVEILLANCE AND VIGILANCE

This sub-system provide a practical solution on establishment and implementation of Post-Market Surveillance (PMS) to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action

Good Manufacturing Practice (cGMP)

The purpose is to enable you to establish and implement an effective tailored cGMP system in line with requirements

CLINICAL EVIDENCE -- IVDR

Under IVDR Clinical Evidence -- Article 56

2(36) ‘clinical evidence’ means clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer

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