May 17, 2020

Diet and exercise tips to control weight loss

resistance training
lean muscle tissue
healthy eating plan
Admin
5 min
Achieve a toned body
Written by Carlos DSouza You can lose fat fast. This is without waking up at 5am to run on an empty stomach; without exercising every day of the week...

Written by Carlos D’Souza

You can lose fat fast. This is without waking up at 5am to run on an empty stomach; without exercising every day of the week; without feeling hungry all the time or completely eliminating your favorite foods and without expensive supplements. Three key things you must commit to doing are regular resistance training in order to build strength and maintain lean muscle tissue, a consistently good healthy eating plan and short and intense or longer and moderate cardiovascular exercise. 

Carlos D’Souza, Personal Trainer and Sports and Remedial Massage Therapist at Results Personal Training Studio in London gives his top tips on how to how to shed those pounds fast and painlessly.  Follow these key principles for fast, efficient and reliable losses in body fat. 

1) Increase muscle tissue with strength training

Muscle is metabolically active within your body and uses up calories to sustain its functions. This means slightly more muscle will lead to a higher resting metabolism.  Regular strength training when done properly will strengthen joints, bones, ligaments, tendons, build muscle and improve flexibility. Strength training builds muscle and prevents muscle loss, so that you don't get skinny and fat. Runners and endurance enthusiasts that do not weight train often have this physique. You will get the best results in the least possible time by doing a free weight routine of compound exercises, consisting of exercises like the squat, dead-lift and bench press.  Perfect form must be used to prevent injury. Seek a well qualified personal trainer to teach you the lifts properly. 

2) Eat whole, unprocessed foods 90 percent of the time

Whole foods are as close as possible to their natural state, without any added sugars, fats or sauces, all of which can affect your metabolism and digestive processes.  The important thing here is to stock up on all your health foods for the week in one big shop and to avoid buying any junk food altogether.  Once unhealthy food has been purchased and it is in the home, temptation is there and is often hard to resist.  The best way to get around this is to simply not buy it in the first place. 

3) Carbs are important

Carbohydrates must be chosen based on their glycaemic index (GI).  Low GI foods are to be eaten 90 percent of the time. This will result in slower digestion and no insulin spike due to a smaller rise in blood sugar levels and therefore will result in less fat storage. 

4) Eat protein with each meal 

Aim to eat 1g of protein per kg of body weight.  Protein also satiates and has the highest thermic effect. Proteins are graded on their biological value (BV, how well your body can assimilate the nutrients from there). Excellent sources are: beef, poultry, fish, dairy and whey.  Remember to rotate what you are eating.  Variety and moderation should be exercised. 

5) Vegetables and fruits

Eat lots of vegetables all day but consume a variety of fruits in the morning only, as the body is better able to digest and use the fruit sugars in the morning.  Vegetables and fruits are relatively low in calories and you can consume a greater quantity of food without an excess of calories.  They are also high in fiber, water, vitamins & minerals.

6) Eat healthy fats

Healthy fats help aid fat loss by satiating and slowing down digestion. Eat healthy fats, like fish oil, olive oil and mixed nuts with each meal. 

7) Keep your body hydrated

Thirst can make you think you’re hungry. Avoid carbonated drinks, alcohol and fruit juice. Try and drink 2 liters of water a day.  Reduce caffeine intake to 1-2 cups of coffee or tea a day.

8)Eat more than three meals a day

Frequent meals prevent hunger by keeping your blood sugar stable. Frequent smaller meals also decrease your stomach size over time, which means you’ll feel full sooner.  Eat every 3 hours and build a pattern and consistency in what you are doing.  Eat at fixed times every day and your body will get hungry at those fixed times.  Example: 7am, 10am, 1pm, 4pm, 6pm, 7pm and 10pm. 

9) Add cardiovascular exercise but don’t overdo it

The right amount and type of cardio training, done at the right time and with the correct nutritional strategies will accelerate fat loss, maintain muscle and leave you feeling fitter, more energetic and vitalised.  Excess cardio training will leave you exhausted, may increase your body's stress hormones and leave you storing more fat and losing muscle.  There is no need to spend more than 30-40 minutes doing cardiovascular exercise, unless you are training for something specifically. 

The cross trainer is a very useful machine, as it is non-weight bearing and much easier to burn more calories per minute and per hour than most other machines.  Running is also very good, but most people do not run with good form and this may lead to injury.  If your running gait is not ideal, improve on it and then run one to three times a week. Boxing, circuit training, swimming and cycling are all great ways to burn calories. 

Key techniques to use are high intensity interval training (H.I.I.T), tabata Intervals, and tempo (threshold) training to maintain heart rates of 70-85 percent for prolonged periods of time.  Always listen to your body, sometimes you simply will not have the vigour to want to perform intensive exercise.  On those days simply perform moderate cardiovascular training sessions but for a longer period of time, there is nothing wrong with doing this sometimes.

Don’t waste your time counting calories: you won’t get fat eating unprocessed foods. Just eat your stomach full and prepare your own food so you have total control over the ingredients.  How you look is largely influenced by what you eat. Lack of muscle mass, high body fat, lack of energy at work or at the gym, bad skin and digestive problems can all be caused by unhealthy nutrition.

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

medicaldevices
supplychain
Brexit
Compliance
Ed Ball
6 min
Ed Ball, Senior Associate at RQM+ , explains how medical device companies can prepare for post-Brexit compliance

Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.

The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.

The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.

The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline. 

This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:

Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking. 

Rigorous Planning
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.

Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.

Authorised Representatives
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.

For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established. 

Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users. 

While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.

Clinical Investigations
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.

Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.

Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.

As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.

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