Quality systems are all about the rigor and discipline needed to ensure continuous improvement, compliance and product consistency.
PharmaLex MedTech can ensure that your employees and partners adhere to requirements by means of a global quality management system and can also advise on special-purpose quality management systems for clinical laboratories, R&D facilities or design houses.
Our medical device quality management system expertise helps you follow best practices, adhere to global compliance requirements and adopt a streamlined, consistent approach to managing the system. Whether for ISO 13485 or the FDA’s Medical Device Single Audit Program or 21 CFR 820 FDA QSR compliance, our team can support any medical device or diagnostic project need.
Inspection Readiness
- Avoid panic or surprises or scrambling to prepare
- Let us assist you with your readiness
Preparation makes the difference. Follow the 8Ps!
We can assist throughout the eights steps of preparedness as follows.
- PURPOSE – Clear and communicated by top management
- PEOPLE – Defining and taking ownership and accountability
- PROCESS – Compliant, effective and efficient
- PRODUCT – Safe, effective and meets client’s needs
- PHYSICAL ENVIRONMENT – Organized, clean and in control
- PLANNING AHEAD – Ready at all times for inspection; audit logistics defined and in place
- PROGRESS – Quality metrics and analysis
- PRACTICE – PRACTICE – PRACTICE – Mock inspections and audits.
Internal Audits and Preaudit Support
Comprehensive multi-site and multi-scope audit services, including areas for improvement
Preaudit Support
Support to prepare for audits as well as during an audit
Supplier Audits
Virtual or in-person supplier audits throughout the world
Attendance at Regulatory Audits and Observation Resolutions
In most jurisdictions, regulatory agencies insist that a product license be held by a legal entity domiciled within the market — typically, a registered company. The local entity is usually known as a marketing authorization holder, authorized representative or sponsor. The entity takes responsibility for the product on the market, files regulatory submissions and conducts communications with the regulator on behalf of the manufacturer, and therefore, the selection of representative or license holder is critical to the orderly continuation of supply.
PharmaLex MedTech provides authorized-representative services in multiple markets. This is more than an administrative solution: we take charge of the entire regulatory process and provide complete professional management of ongoing compliance so that you can focus on building your business.
As a specialist market representative, we take responsibility for regulatory compliance and provide the interface with regulatory authorities. This gives you the peace of mind that your regulatory compliance is being managed professionally. And it ensures that distribution arrangements are independently structured for maximum commercial benefit.