Comprehensive QMS Services for Medical Device ISO 13485 & MDSAP Compliance

Ensure Excellence in Medical Device Development and Manufacturing

At Sushvin Consultancy Services, we understand the critical importance of maintaining a robust Quality Management System (QMS) in the medical device industry.

Our expert consultancy services are designed to help you navigate complex regulatory requirements, enhance product quality, and achieve operational excellence.

Our comprehensive services help you implement and maintain QMS compliant with ISO 13485 and MDSAP standards, facilitating global market access.

Quality Management Systems for medical devices in UK, USA, EU, and Globally.

Regulatory Compliance - ISO 13485, FDA 21 CFR Part 820

Why QMS Matters

A well-implemented QMS is the backbone of quality assurance in medical device development and is crucial for rregulatory compliance, product quality, and patient safety. It provides the necessary framework to manage processes, ensure consistent product quality, and meet regulatory requirements across different markets. It ensures that every aspect of your product lifecycle—from design and development to manufacturing and post-market activities—meets stringent regulatory standards and customer expectations.

Key Benefits of an Effective QMS:

Regulatory Compliance: Stay compliant with global standards such as ISO 13485, FDA 21 CFR Part 820, and other industry-specific regulations.
Product Quality & Safety: Consistently deliver safe and effective medical devices that meet or exceed quality benchmarks.
Operational Efficiency: Streamline processes to reduce waste, lower costs, and improve resource management.
Risk Management: Identify, assess, and mitigate risks associated with medical device production and management.
Continuous Improvement: Foster a culture of continuous improvement with systematic reviews and updates to your quality processes.

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Our QMS Implementation Services

Setting up a robust QMS from scratch? Our team will guide you through every step, ensuring that your system aligns with regulatory requirements and industry best practices. We offer:

Initial Gap Analysis: Assess your current quality practices and identify areas for improvement as per ISO 13485 requirements.
System Design & Development: Tailor a QMS that fits your specific needs, including documentation, processes, and procedures.
Regulatory Alignment: Ensure your QMS complies with ISO 13485, FDA, and other relevant standards.
Training & Support: Equip your team with the knowledge and skills to effectively implement and maintain the QMS.

QMS Implementation Services in UK, EU and Globally- Sushvin Consultion Services Limited

Maintaining a QMS is crucial for ongoing compliance and continuous improvement. Our maintenance services include:

Periodic Audits: Conduct internal and external audits to ensure ongoing compliance and identify areas for enhancement.
Process Improvement: Analyse performance data and feedback to refine and optimize your quality management processes.
Regulatory Updates: Keep your QMS updated with the latest regulatory changes and industry trends.
Documentation Management: Ensure all quality documentation is current, accurate, and easily accessible.

Navigating the certification process can be challenging. We offer comprehensive support to help you achieve and maintain certifications:

QMS for ISO 13485 compliance, Compliance and Certification Support for medical devices

auditing solutions for medical devices, ISO 13485:2016 Implementation

Notified Body & Competent Authority Audits:
Notified Bodies conduct conformity assessments in line with EU Directives, which typically involve auditing a manufacturer’s quality system and reviewing relevant technical documentation based on device classification. They evaluate medical devices (MDs) and in-vitro diagnostics (IVDs), issuing CE marks that are essential for market entry in the EU. Preparing for these audits requires significant resources, and if not approached correctly, manufacturers may face observations that can be time-consuming to resolve; however, when a Lead Auditor understands the Notified Body's requirements, clients often pass with minimal or no observations. Sushvin’s consultants are lead auditors who can provide assistance with Notified Body (NB) and Competent Authority (CA) audits and help resolve deficiencies identified in the audit report.

Internal Audits:
As per ISO 13485:2016 clause 8.2.4 and 21 CFR 820.22, a Medical Device Manufacturer’s Quality Management System must undergo an impartial audit conducted by qualified personnel following a documented procedure. At Sushvin, all our consultants are trained in ISO 13485:2016 internal auditing and can assist your organization in achieving compliance through annual audits. Internal audits are essential for continuous improvement and ensuring readiness for external audits.
Supplier Audits:
According to ISO 13485:2016, legal manufacturers must conduct supplier audits for new or potential suppliers and perform annual evaluations. Sushvin Consultancy Services assists clients with second-party audits, saving valuable time and resources by providing experienced auditors to evaluate suppliers. Whether it involves distributors, raw material providers, contract manufacturing, sterilization, or packaging, our trained staff can conduct audits tailored to your specific criteria and also offer training for supplier audits.

Regulatory Approach For Market Entry

ISO 13485:2016 Implementation

ISO 13485:2016 is a globally recognized standard that establishes the framework for creating and maintaining an effective Quality Management System (QMS).

We assist you in implementing this standard to ensure compliance and achieve excellence in the UK, Europe, and other international markets.

MDSAP
Implementation

The Medical Device Single Audit Program (MDSAP) allows for a single audit to meet the regulatory requirements of multiple jurisdictions, including the United States, Canada, Brazil, Australia, and Japan.

We support you in implementing MDSAP, which builds on ISO 13485 and integrates specific regulatory requirements from each country.