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Commercial & Quality

MedtechBOSS offers a comprehensive range of regulatory and quality management services tailored to support medtech companies in bringing new medical devices to market efficiently and compliantly.

 

Our expertise spans regulatory strategy development, ensuring early alignment with country-specific requirements to streamline market entry, and leveraging our GDPMDS-certified dealer licenses for importation and distribution in Singapore, particularly for start-ups.

 

We also specialize in the preparation of Technical Documentation (TD) or Medical Device Files (MDF), critical for regulatory submissions, by providing end-to-end support, from gap analysis to full document setup in accordance with global standards such as EU MDR and US FDA regulations.

 

Additionally, we assist with Quality Management System (QMS) compliance, offering complete QMS setup and audit support to meet international standards, including ISO 13485, SS 620, and MDSAP, ensuring our clients achieve and maintain regulatory approval efficiently and cost-effectively.

Regulatory Strategy

Regulatory strategy is a foundational document that outlines the objectives, planning and the critical pathway to bring a new medical device to a particular market by meeting all relevant regulatory requirements. A solid regulatory strategy established early in the product development phase, can help the company to plan resources and time efficiently and effectively because the product can be designed in such a way that the country-specific requirements are met in one shot. Therefore, the strategy should be established early in the product development phase before the design freezes. Regulatory Strategy is also a regulatory obligation under the EU MDR in Europe.


Our team of regulatory experts and ex-regulators from the health authorities can help clients to build their regulatory strategy based on the targeted market to ensure regulatory compliance and market access tailored to specific products at a lower cost and shorter time-to-market.

Dealer License Tapping

MedtechBOSS is a GDPMDS-certified company and holds both the importer and wholesaler licenses. We provide an option for companies, especially start-ups, to leverage on our dealer licenses for their commercial activities in Singapore. By tapping on our licenses, they can begin their importation and distribution without the need to establish their own quality system, significantly reducing costs and streamlining the process. Our vast regulatory expertise and experiences make MedtechBOSS the ideal choice for companies looking to enter the Singapore market cost-effectively and efficiently.

Technical Documentation (TD)/
Medical Device File (MDF)

Medical device file (MDF) or Technical Documents (TD) is an essential document required for the submission for all medical devices and IVDs to explore into their intended market.
Our team of engineers, clinical experts and regulatory consultants have helped variety of clients to set up their technical file which consists of information such as designs, testing, clinical evaluation and risk management, to demonstrate compliance with applicable regulatory requirements for different authorities. As part of requirements under ISO 13485 standards, MedTech companies are required to maintain one or more MDF for each medical device type or family referencing documents generated to demonstrate conformity.
A medical device file shall document all the information on how the medical device was designed, developed and manufactured throughout the product lifecycle.

 

The depth and detail of the information contained in the technical documentation will depend on:

  • the classification of the device; and

  • the complexity of the device.


Country-specific requirements should also be considered early in the preparation of the Technical Documentation including technical to labelling requirements. The MDF can be prepared according to EU MDR, US FDA and local regulations to ensure compliance for registration of the applicable markets.

MedtechBOSS can help you with:
1. Gap analysis and closure
2. Clinical Evaluation Plan and Report Writing
3. Post-market surveillance documentations (PSUR, PMCF plan and report)
4. Summary of Safety and Clinical Performance
5. Full TD/MDF setup
 

Quality Management System Compliance

A quality management system, is a collection of policies, processes, documented procedures,
and records that must be followed by a company by a set of internal rules tailored to the organizational needs of the product or service you provide to customers and patients. We offer clients a range of services including full QMS set-up from preparation of documents for certification, RA/QA support for supplier audit, internal audit and external audit.

Our consultants with lead auditor experiences in manufacturing facilities of different companies, can offer their help on different quality standards and regulations compliance as below:

 

  • ISO 13485:2016 Quality Management System-Medical Device

  • SS 620:2016 (2021) Good distribution practice for medical devices - Requirements

  • EU MDR 2017/745 Medical Device Regulation

  • EU MDR 2017/746 In vitro diagnostic (IVD) Medical Device Regulation

  • U.S. FDA Quality System Regulation (QSR)

  • Medical Device Single Audit Program (MDSAP)

  • UK Medical Device Regulation 2002

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