ISO 13485

Delivering validation services tailored to the organizational needs and persistent follow-up until completion of the regulatory process. Detailed assistance will be provided to the clients in all aspects of process, product and systems validation. Right from designing Validation Master Plans to execution of DQ/IQ/OQ/PQs, Medra+ has a solid grounding in all forms of validation, across all business entities in EU, ASEAN and US regions.

• Providing high quality and practical training to be implemented in the workplace. Training courses are delivered by highly experienced consultants in the related field.
• Medra+ helps in implementing comprehensive quality system auditing portfolio, ISO certification assistance, batch records documentation, complaint handling, CAPA, adverse events, Vigilance, supplier Evaluation, Training as well as realignment and remediation of ineffective systems.

• Constant follow-up on Risk Management and risk FMEA as per requirements.
• Identification of applicable regulatory requirements and ensuring 100% compliance towards the same.
• Full documentation support right from manufacturing to product registration approvals including preclinical testing and bench mark testing.

• Micro–level survey for every activity of the organization and preparation of detailed Gap Analysis Report.
• Medra+ actively involved clinical evaluation protocols and CER MEDDEV 2.7.1

Medra+ assists in providing On-site Internal Audit and management review meeting support