Medical Device Regulatory Expertise
Navigating the complex world of medical device regulations can be challenging. Whether you are a startup or an established manufacturer, our experts can guide you through the regulatory processes, assist in preparing and submitting technical files, and ensure compliance with the upcoming EU MDR and IVDR regulations.
Technical Documentation Writing and Review
Accurate and comprehensive technical documentation is crucial for medical device manufacturers. Our regulatory professionals are well-versed in the requirements of technical documentation and can assist you in writing and reviewing various documents, including technical files, design dossiers, and risk assessments. We ensure that your technical documentation meets the relevant regulations and guidelines, minimizing the risk of delays or rejections during the regulatory review process.
Regulatory Intelligence: Staying Ahead of the Curve
In the ever-changing world of medical device regulations, it is essential to stay well-informed and updated. Our team at Aspect Packaging constantly monitors the regulatory landscape, keeping track of new or revised regulations, guidelines, and standards. We provide our clients with regulatory intelligence, offering strategic insights to help them adapt and comply with the evolving regulatory requirements. Our proactive approach ensures that our clients are always ahead of the curve, enabling them to make informed decisions and stay competitive in the market.
CE Conformity Assistance
Obtaining CE conformity is a critical step for medical device manufacturers to market their products in the European Union. Our team provides comprehensive assistance with CE conformity activities. We guide you through the conformity assessment process, help you compile the necessary documentation, and ensure that your product meets the essential requirements outlined in the Medical Devices Regulation (MDR). With our guidance, you can navigate the complexities of CE conformity with confidence.
Quality Management System Activities as per EN ISO 13485
Implementing and maintaining a robust Quality Management System (QMS) is vital for medical device manufacturers. At Aspect Packaging, we assist clients in aligning their Quality Management System activities with the requirements of EN ISO 13485. Aspect packaging has extensive knowledge of the standard and can help you develop, implement, and maintain an effective QMS that complies with the relevant regulations. We provide guidance in developing quality manuals, procedures, and work instructions, and offer training and support to ensure the successful implementation and maintenance of your QMS.
Other Services
Regulatory Affairs and CMC
We offer regulatory affairs and Chemistry, Manufacturing, and Controls services. We provide full lifecycle management and eCTD maintenance support.
Importation and Warehousing
Aspect Packaging offers comprehensive importation and warehousing services tailored to meet the unique needs of your company.